Intrathecal Paracetamol Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Short Knee Procedures
Sponsor
Sintetica SA (Industry)
Overall Status
Completed
CT.gov ID
NCT03428230
Collaborator
Cross Research S.A. (Industry)
60
1
4
14.5
4.1
Study Details
Study Description
Brief Summary
This is a phase II, single centre, randomised, parallel-group, double-blind, three doses, placebo-controlled, exploratory efficacy and safety study. The objective of this study is to investigate the efficacy and safety of a single intrathecal injection of Paracetamol 3% (30 mg/mL) administered at 3 doses to 3 active treatment groups, as compared to placebo, for post-operative analgesia in knee procedures up to 40 min duration performed under spinal anaesthesia with Chloroprocaine HCl 1%.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Eligible patients undergoing elective short-duration knee procedures up to 40 min duration will be randomised into 4 treatment groups (15 patients per group) to receive either one of the 3 single doses of Paracetamol 3% (D1: 30 mg, D2: 60 mg, D3: 90 mg) or the placebo solution (P: 0.9% saline solution) by intrathecal injection (IT), according to the randomised, parallel-group design.
Immediately after IT paracetamol or placebo administration, all patients will receive a single IT dose of Chloroprocaine HCl 1% (Non-investigational medicinal product, NIMP) according to the Summary of Product Characteristics indications. The time interval between paracetamol IT and chloroprocaine IT injections should not exceed 2 min.
The study will include a screening phase (Visit 1, Day -21/-1), a treatment phase (IMP IT administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a follow-up phase including an observation period (Visit 3), a final visit and two follow-ups (24 h post-dose and day 7±1).
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Eligible patients will be randomised into four treatment groups (15 patients/group) to receive either one of the three single doses of Paracetamol 3% (30 mg, 60 mg, 90 mg) or placebo solution (1 mL, 2 mL, 3 mL) according to the randomised, parallel-group design.Eligible patients will be randomised into four treatment groups (15 patients/group) to receive either one of the three single doses of Paracetamol 3% (30 mg, 60 mg, 90 mg) or placebo solution (1 mL, 2 mL, 3 mL) according to the randomised, parallel-group design.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The study will be double-blind. Neither the Investigator/co-investigators/study nurses involved in the clinical study procedures, nor will the patients be aware of the administered treatment. At the site, syringes for injection will then be prepared by a person not involved in any other study-related activities where a bias is possible.
Primary Purpose:
Supportive Care
Official Title:
Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Knee Procedures of Short Duration
Actual Study Start Date
:
Aug 6, 2018
Actual Primary Completion Date
:
Oct 22, 2019
Actual Study Completion Date
:
Oct 22, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 30 mg Paracetamol 3% (1 mL) 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) |
Drug: 30 mg Paracetamol 3% (1 mL)
Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection
Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min.
Other Names:
|
| Experimental: 60 mg Paracetamol 3% (2 mL) 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) |
Drug: 60 mg Paracetamol 3% (2 mL)
Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection
Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min.
Other Names:
|
| Experimental: 90 mg Paracetamol 3% (3 mL) 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) |
Drug: 90 mg Paracetamol 3% (3 mL)
Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection
Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min.
Other Names:
|
| Placebo Comparator: Placebo, 0.9% saline solution Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) |
Drug: Placebo, 0.9% saline solution
Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
Other Names:
Drug: NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection
Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pain Intensity at Rest Evaluated Using a 0-100 mm VAS [Pain intensity at rest evaluated using a 0-100 mm VAS at baseline (within 30 min before NIMP IT injection, 0 h), 1, 1.25, 1.5, 1.75, 2 h after NIMP IT injection, then every 30 min after NIMP IT injection until eligibility for home discharge.]
The study primary efficacy measures will be the VAS scores at each predefined time-point after the anaesthetic intrathecal injection until eligibility for home discharge ( VAS scale is 0-100 mm, where 0 is no pain and 100 is maximum pain)
Secondary Outcome Measures
- Pain at Rest AUCt1-t2 [Up to 4 hours after injection]
AUC t1-t2 is defined as the area under the pain intensity curve at the specified time-intervals
- Pain at Rest AUClast [Up to 24 hours after injection]
AUClast is defined as the area under the pain intensity curve from 0 h up to the last assessment time
- Time to First Postoperative Analgesia (Level 1 or 2) [Up to 24 hours after surgery]
Postoperatively, patients will be administered an analgesic as needed. Post-operative analgesia could include Ketorolac i.v. [Toradol] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia). The administered analgesic (level 1 or 2), analgesic dose and intake frequency will be decided according to the reported surgery-related pain intensity. Post-operatively, patients were administered an analgesic, as needed. Post-operative analgesia could include Ketorolac i.v. [Toradol] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia).
- Partecipants to Received Level 1 Analgesia [from surgery day to 24 hours after surgery]
Partecipants to received Ketorolac i.v. [Toradol] 30 mg administration (level 1 analgesia)
- Partecipants Received Level 2 Analgesia [from surgery day to 24 hours after surgery]
Partecipants received Tramadol i.v. 1 mg/kg administration (level 2 analgesia)
- Total Number of Partecipants Receiving Analgesic 1 [From surgery day to 24 hours after surgery]
Total number of partecipants receiving Ketorolac i.v. [Toradol] 30 mg
- Total Number of Partecipants Receiving Analgesic 2 [from surgery day to 24 hours after surgery]
Total Number of Partecipants Receiving Tramadol i.v. 1 mg/kg
- Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End [Form surgery day to 2 hours after surgery end]
Percentage of patients requiring analgesia (level 1 or level 2) in the first 2 h after surgery end
- Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End [from surgery day to 4 hours after surgery end]
Percentage of patients requiring analgesia (level 1 or level 2) in the first 4 h after surgery end
- Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge [from surgery day to 24 hours after surgery]
Percentage of patients requiring analgesia (level 1 or level 2) from surgery end until eligibility for home discharge
- Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge [from surgery day to 24 hours after surgery]
Percentage of patients requiring level 1 analgesia from surgery end until eligibility for home discharge
- Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge [from surgery day to 24 hours after surgery]
Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Home Discharge
- Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia [from surgery day to 24 hours after surgery]
Percentage of patients requiring supplementary analgesia, other than the planned level 1 or 2 analgesia
- Percentage of Patients Requiring Rescue Anaesthesia [from surgery day to 1 hour after injection]
Percentage of patients requiring rescue anaesthesia
- Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery) [Up to 20 minutes after injection]
Spinal block/Readiness for surgery is defined as the presence of an adequate motor block (Bromage's score ≥ 2) and loss of Pinprick sensation, according to the Investigator's opinion. Time to readiness for surgery is defined as the time from the spinal injection (time 0 h) to achievement of readiness for surgery.
- Maximum Sensory Block [Intraoperative]
Maximum level of sensory block
- Time to Sensory Block [Intraoperative]
Time to maximum level of sensory block (bilateral Pinprick test using a 20-G hypodermic needle)
- Time to Regression of Spinal Block [Up to 4 hours after injection]
Time period from spinal injection to the complete regression of sensory block to S1.
- Time to Ambulation [Up to 24 hours after injection]
Time to unassisted ambulation
- Time to First Urine [Up to 24 hours after injection]
Time to first spontaneous urine voiding
- Time to Eligibility for Discharge [Up to 24 hours after injection]
Time to eligibility for home discharge
Other Outcome Measures
- Number of Participants With Neurological Complications Including TNS [From anaesthetic intrathecal injection up to day 7±1 (i.e. 6±1 days after analgesic/anaesthetic IT injection and surgery)]
Number of Participants with Neurological Complications Including TNS at 24 h post-dose and at day 7±1
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Informed consent: signed written informed consent before inclusion in the study
-
Sex, age and surgery: male/female patients, 18-80 years old (inclusive), scheduled for short duration (up to 40 min) knee procedures
-
Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
-
ASA physical status: I-III
-
Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.
Exclusion Criteria:
-
Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to spinal anaesthesia. History of neuromuscular diseases to the lower extremities
-
ASA physical status: IV-V
-
Further anaesthesia: patients expected to require further anaesthesia
-
Allergy: ascertained or presumptive hypersensitivity to the active principles (paracetamol and/or ester type anaesthetics) and/or formulations' ingredients or related drugs, non-steroidal anti-inflammatory drugs and/or opioid derivatives; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers could affect the outcome of the study
-
Chronic pain syndromes: patients with chronic pain syndromes taking opioids, anticonvulsant agents or chronic analgesic therapy
-
Pain assessment: patients anticipated to be unable to make a reliable self-report of pain intensity
-
Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric and neurological diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid disease, diabetes, other neuropathies, history or evidence of heart failure. History of severe head trauma that required hospitalisation, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or CNS mass lesion
-
Medications: medication known to interfere with the extent of spinal blocks for 2 weeks before the start of the study. Paracetamol formulations, other than the investigational product, for 2 weeks before the start of the study and during the study. Hormonal contraceptives for females are allowed. Anti-hypotensive, anti-bradycardia (e.g. ephedrine, atropine, Ringer's solution), anti-haemetic and anti-nausea medications will be allowed
-
Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
-
Drug, alcohol: history of drug or alcohol abuse according to the Investigator's opinion
-
Pregnancy and lactation: positive pregnancy test at screening (if applicable), pregnant or lactating women [The pregnancy test will be performed to all fertile women and to all women up to 55 years old, if not in proven menopause (available laboratory test confirming menopause or surgically sterilised)]
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anaesthesiology, Clinica Ars Medica | Gravesano | Switzerland | 6929 |
Sponsors and Collaborators
- Sintetica SA
- Cross Research S.A.
Investigators
- Principal Investigator: Claudio Camponovo, MD, Department of Anaesthesiology, Clinica Ars Medica, Via Cantonale, CH-6929 Gravesano, Switzerland
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Sintetica SA
ClinicalTrials.gov Identifier:
NCT03428230
Other Study ID Numbers:
- PAR.3-01-2017
- CRO-17-133
First Posted:
Feb 9, 2018
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Period Title: Overall Study | ||||
| STARTED | 15 | 15 | 15 | 15 |
| COMPLETED | 15 | 15 | 15 | 15 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Total of all reporting groups |
| Overall Participants | 15 | 15 | 15 | 15 | 60 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
46.1
(10.9)
|
39.7
(15.5)
|
40.1
(12.8)
|
45.5
(13.6)
|
42.85
(13.2)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
2
13.3%
|
2
13.3%
|
2
13.3%
|
2
13.3%
|
8
13.3%
|
| Male |
13
86.7%
|
13
86.7%
|
13
86.7%
|
13
86.7%
|
52
86.7%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
15
100%
|
15
100%
|
15
100%
|
15
100%
|
60
100%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||
| Switzerland |
15
100%
|
15
100%
|
15
100%
|
15
100%
|
15
25%
|
Outcome Measures
| Title | Pain Intensity at Rest Evaluated Using a 0-100 mm VAS |
|---|---|
| Description | The study primary efficacy measures will be the VAS scores at each predefined time-point after the anaesthetic intrathecal injection until eligibility for home discharge ( VAS scale is 0-100 mm, where 0 is no pain and 100 is maximum pain) |
| Time Frame | Pain intensity at rest evaluated using a 0-100 mm VAS at baseline (within 30 min before NIMP IT injection, 0 h), 1, 1.25, 1.5, 1.75, 2 h after NIMP IT injection, then every 30 min after NIMP IT injection until eligibility for home discharge. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| baseline |
9.6
(20)
|
16.9
(17.4)
|
18.4
(26.4)
|
8.1
(14.8)
|
| 1 hour after NIMP |
0.1
(0.3)
|
0.1
(0.5)
|
3.4
(11.5)
|
0
(0)
|
| 1.25 hour after NIMP |
4.6
(11.4)
|
1.9
(5.1)
|
6.2
(13.7)
|
0.6
(1.3)
|
| 1.50 hour after NIMP |
5.9
(13.2)
|
4.5
(10.2)
|
16.4
(23.6)
|
1.2
(2.1)
|
| 1.75 hour after NIMP |
9.5
(16.5)
|
15.1
(16.3)
|
21.4
(24.3)
|
3.6
(6.1)
|
| 2 hours after NIMP |
14.1
(24.6)
|
17.8
(19)
|
22.8
(23.2)
|
3.9
(8.7)
|
| 2.5 hours after NIMP |
16.9
(22.8)
|
8.7
(7.1)
|
14.7
(15.8)
|
7.2
(8.2)
|
| 3 hours after NIMP |
21
(27.7)
|
9.6
(12.8)
|
7.3
(13)
|
10.4
(15.4)
|
| 3.5 hours after NIMP |
19.7
(21.4)
|
6.8
(11.4)
|
14.2
(25.7)
|
11.4
(16.8)
|
| 4 hours after NIMP |
6.8
(8.3)
|
13.3
(18.1)
|
15.3
(19.1)
|
0
(0)
|
| 4.5 hours after NIMP |
2.5
(3.5)
|
0
(0)
|
2
(2.6)
|
0
(0)
|
| before discharge |
3.7
(4.7)
|
4.1
(5.6)
|
2.9
(4.5)
|
11.3
(7.7)
|
| Title | Pain at Rest AUCt1-t2 |
|---|---|
| Description | AUC t1-t2 is defined as the area under the pain intensity curve at the specified time-intervals |
| Time Frame | Up to 4 hours after injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| AUC 0-2 hours |
13
(13)
|
14.8
(12.5)
|
26.4
(30.1)
|
4.4
(7.1)
|
| AUC 0-4 hours |
34.6
(29.6)
|
26
(10.9)
|
92.2
(69.4)
|
49.7
(21.7)
|
| Title | Pain at Rest AUClast |
|---|---|
| Description | AUClast is defined as the area under the pain intensity curve from 0 h up to the last assessment time |
| Time Frame | Up to 24 hours after injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Mean (Standard Deviation) [score on a scale*h] |
34
(41.3)
|
24.7
(15.7)
|
42
(50.3)
|
15.7
(23.3)
|
| Title | Time to First Postoperative Analgesia (Level 1 or 2) |
|---|---|
| Description | Postoperatively, patients will be administered an analgesic as needed. Post-operative analgesia could include Ketorolac i.v. [Toradol] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia). The administered analgesic (level 1 or 2), analgesic dose and intake frequency will be decided according to the reported surgery-related pain intensity. Post-operatively, patients were administered an analgesic, as needed. Post-operative analgesia could include Ketorolac i.v. [Toradol] 30 mg (level 1 analgesia) and/or Tramadol i.v. 1 mg/kg (level 2 analgesia). |
| Time Frame | Up to 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Nine (9) patients in D1, 10 in D2, 8 in D3 and 14 in P treatment group did not require postoperative analgesia and were censored in the time to first post-operative analgesia analysis |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 11 | 8 | 14 | 1 |
| 0-2 hours |
5
33.3%
|
3
20%
|
7
46.7%
|
0
0%
|
| 0-4 hours |
6
40%
|
5
33.3%
|
7
46.7%
|
1
6.7%
|
| Title | Partecipants to Received Level 1 Analgesia |
|---|---|
| Description | Partecipants to received Ketorolac i.v. [Toradol] 30 mg administration (level 1 analgesia) |
| Time Frame | from surgery day to 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Count of Participants [Participants] |
6
40%
|
5
33.3%
|
7
46.7%
|
1
6.7%
|
| Title | Partecipants Received Level 2 Analgesia |
|---|---|
| Description | Partecipants received Tramadol i.v. 1 mg/kg administration (level 2 analgesia) |
| Time Frame | from surgery day to 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Count of Participants [Participants] |
2
13.3%
|
0
0%
|
4
26.7%
|
0
0%
|
| Title | Total Number of Partecipants Receiving Analgesic 1 |
|---|---|
| Description | Total number of partecipants receiving Ketorolac i.v. [Toradol] 30 mg |
| Time Frame | From surgery day to 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Count of Participants [Participants] |
6
40%
|
5
33.3%
|
7
46.7%
|
1
6.7%
|
| Title | Total Number of Partecipants Receiving Analgesic 2 |
|---|---|
| Description | Total Number of Partecipants Receiving Tramadol i.v. 1 mg/kg |
| Time Frame | from surgery day to 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Count of Participants [Participants] |
2
13.3%
|
0
0%
|
4
26.7%
|
0
0%
|
| Title | Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End |
|---|---|
| Description | Percentage of patients requiring analgesia (level 1 or level 2) in the first 2 h after surgery end |
| Time Frame | Form surgery day to 2 hours after surgery end |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Count of Participants [Participants] |
5
33.3%
|
3
20%
|
7
46.7%
|
0
0%
|
| Title | Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End |
|---|---|
| Description | Percentage of patients requiring analgesia (level 1 or level 2) in the first 4 h after surgery end |
| Time Frame | from surgery day to 4 hours after surgery end |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Count of Participants [Participants] |
6
40%
|
5
33.3%
|
7
46.7%
|
1
6.7%
|
| Title | Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge |
|---|---|
| Description | Percentage of patients requiring analgesia (level 1 or level 2) from surgery end until eligibility for home discharge |
| Time Frame | from surgery day to 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 14 |
| Count of Participants [Participants] |
6
40%
|
5
33.3%
|
7
46.7%
|
1
6.7%
|
| Title | Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge |
|---|---|
| Description | Percentage of patients requiring level 1 analgesia from surgery end until eligibility for home discharge |
| Time Frame | from surgery day to 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Count of Participants [Participants] |
6
40%
|
5
33.3%
|
7
46.7%
|
1
6.7%
|
| Title | Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge |
|---|---|
| Description | Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Home Discharge |
| Time Frame | from surgery day to 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Count of Participants [Participants] |
2
13.3%
|
0
0%
|
4
26.7%
|
0
0%
|
| Title | Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia |
|---|---|
| Description | Percentage of patients requiring supplementary analgesia, other than the planned level 1 or 2 analgesia |
| Time Frame | from surgery day to 24 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| level 1 |
6
40%
|
5
33.3%
|
7
46.7%
|
1
6.7%
|
| level 2 |
2
13.3%
|
0
0%
|
4
26.7%
|
0
0%
|
| Title | Percentage of Patients Requiring Rescue Anaesthesia |
|---|---|
| Description | Percentage of patients requiring rescue anaesthesia |
| Time Frame | from surgery day to 1 hour after injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Count of Participants [Participants] |
14
93.3%
|
15
100%
|
15
100%
|
14
93.3%
|
| Title | Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery) |
|---|---|
| Description | Spinal block/Readiness for surgery is defined as the presence of an adequate motor block (Bromage's score ≥ 2) and loss of Pinprick sensation, according to the Investigator's opinion. Time to readiness for surgery is defined as the time from the spinal injection (time 0 h) to achievement of readiness for surgery. |
| Time Frame | Up to 20 minutes after injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Median (Inter-Quartile Range) [minutes] |
5
|
5
|
2
|
5
|
| Title | Maximum Sensory Block |
|---|---|
| Description | Maximum level of sensory block |
| Time Frame | Intraoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| T1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| T2 |
1
6.7%
|
0
0%
|
0
0%
|
0
0%
|
| T3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| T4 |
0
0%
|
0
0%
|
1
6.7%
|
1
6.7%
|
| T5 |
0
0%
|
1
6.7%
|
1
6.7%
|
1
6.7%
|
| T6 |
1
6.7%
|
1
6.7%
|
1
6.7%
|
1
6.7%
|
| T7 |
0
0%
|
1
6.7%
|
0
0%
|
0
0%
|
| T8 |
7
46.7%
|
0
0%
|
6
40%
|
6
40%
|
| T9 |
0
0%
|
3
20%
|
2
13.3%
|
0
0%
|
| T10 |
3
20%
|
5
33.3%
|
1
6.7%
|
4
26.7%
|
| T11 |
2
13.3%
|
3
20%
|
2
13.3%
|
1
6.7%
|
| T12 |
0
0%
|
1
6.7%
|
0
0%
|
1
6.7%
|
| L1 |
1
6.7%
|
0
0%
|
1
6.7%
|
0
0%
|
| L2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| L3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| L4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| L5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| S1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| S2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| S3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| S4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| S5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Time to Sensory Block |
|---|---|
| Description | Time to maximum level of sensory block (bilateral Pinprick test using a 20-G hypodermic needle) |
| Time Frame | Intraoperative |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Median (95% Confidence Interval) [minutes] |
10
|
10
|
10
|
10
|
| Title | Time to Regression of Spinal Block |
|---|---|
| Description | Time period from spinal injection to the complete regression of sensory block to S1. |
| Time Frame | Up to 4 hours after injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Median (95% Confidence Interval) [minutes] |
100
|
100
|
90
|
95
|
| Title | Time to Ambulation |
|---|---|
| Description | Time to unassisted ambulation |
| Time Frame | Up to 24 hours after injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Median (95% Confidence Interval) [minutes] |
139
|
115
|
125
|
125
|
| Title | Time to First Urine |
|---|---|
| Description | Time to first spontaneous urine voiding |
| Time Frame | Up to 24 hours after injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Median (95% Confidence Interval) [minutes] |
155
|
140
|
145
|
150
|
| Title | Time to Eligibility for Discharge |
|---|---|
| Description | Time to eligibility for home discharge |
| Time Frame | Up to 24 hours after injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Median (95% Confidence Interval) [minutes] |
170
|
165
|
170
|
168
|
| Title | Number of Participants With Neurological Complications Including TNS |
|---|---|
| Description | Number of Participants with Neurological Complications Including TNS at 24 h post-dose and at day 7±1 |
| Time Frame | From anaesthetic intrathecal injection up to day 7±1 (i.e. 6±1 days after analgesic/anaesthetic IT injection and surgery) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution |
|---|---|---|---|---|
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. |
| Measure Participants | 15 | 15 | 15 | 15 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Adverse events throughout the study 48 hours | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution | ||||
| Arm/Group Description | 30 mg Paracetamol 3% (1 mL), solution for injection, single dose by intrathecal injection (IT) 30 mg Paracetamol 3% (1 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 60 mg Paracetamol 3% (2 mL), solution for injection, single dose by intrathecal injection (IT) 60 mg Paracetamol 3% (2 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | 90 mg Paracetamol 3% (3 mL), solution for injection, single dose by intrathecal injection (IT) 90 mg Paracetamol 3% (3 mL): Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | Placebo, 0.9% saline solution (1 mL, 2 mL or 3 mL), solution for injection, single dose by intrathecal injection (IT) Placebo, 0.9% saline solution: Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures. NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection: Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min. | ||||
All Cause Mortality |
||||||||
| 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) | ||||
Serious Adverse Events |
||||||||
| 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| 30 mg Paracetamol 3% (1 mL) | 60 mg Paracetamol 3% (2 mL) | 90 mg Paracetamol 3% (3 mL) | Placebo, 0.9% Saline Solution | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/15 (20%) | 0/15 (0%) | 4/15 (26.7%) | 3/15 (20%) | ||||
| Cardiac disorders | ||||||||
| bradycardia | 0/15 (0%) | 0 | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 | 1/15 (6.7%) | 1 |
| Nervous system disorders | ||||||||
| headache | 3/15 (20%) | 3 | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 | 1/15 (6.7%) | 1 |
| Vascular disorders | ||||||||
| hypotension | 0/15 (0%) | 0 | 0/15 (0%) | 0 | 2/15 (13.3%) | 2 | 1/15 (6.7%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr.Elisabetta Donati, Corporate Director Scientific Affairs |
|---|---|
| Organization | Sintetica SA |
| Phone | +41.91.640.42.50 |
| edonati@sintetica.com |
Responsible Party:
Sintetica SA
ClinicalTrials.gov Identifier:
NCT03428230
Other Study ID Numbers:
- PAR.3-01-2017
- CRO-17-133
First Posted:
Feb 9, 2018
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021