PASS: Observational Study on 2-chloroprocaine Hydrochloride 1%
Study Details
Study Description
Brief Summary
The present study aims to evaluate the relationship between spinal block with 1% solution of 2-chloroprocaine hydrochloride and the onset of all possible neurological adverse events, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome (CES).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Primary endpoint :Incidence of neurological complications (Transient and Permanent complications; e.g. transient neurological symptoms, arachnoiditis, cauda equina syndrome).Two follow-up questionnaires are foreseen, at 24 h and 7 days after time of spinal injection (Tsp), to gather all possible neurological complications, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome (CES).Patients scheduled for elective surgery will be informed about the aims, procedures and possible risks of the study and will be asked to sign the informed consent form for the inclusion in the trial, from day -14 to day of surgery (visit 1, Day 0).This observational study is planned to collect data on patients undergoing surgery under intrathecal anesthesia with chloroprocaine hydrochloride, primarily to assess the occurrence of all possible neurological adverse events (with particular attention to TNS and CES). The mandatory follow-ups of the study are at 24 h and 7 days (-1/+2) after anaesthesia. In case of signs of neurological complications, the patient has to undergo to a medical visit at the hospital by the relevant specialists (anaesthetist, surgeon, neurologist). In order to characterise the occurred adverse event, a complete analysis evaluation has to be conducted, as CT, MRI, Electromyography, etc. following the indication of the specialists. In case of persistent neuropathy the patient needs to be accurately followed according to the internal hospital procedure. In the meantime, a full screening of the patient's clinical history together with a detailed analysis of the relevant variables, potentially related to the adverse event, have to be carried out.
Therefore, the physician will take all appropriate measures to ensure the safety of the patients, notably he/she should follow up the outcome of any Adverse Events (clinical signs, laboratory values or other, etc.) until the return to normal or consolidation of the patient's condition. In case of any Serious Adverse Event, the patient has to be followed up until clinical recovery is complete and laboratory results have returned to normal, or until progression has been stabilized. The follow-up will continue after the patient has left the study.
Study Design
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events [assessed at 24h and 7(-1/+2) days after surgery, total reported]
Number of Participants with neurological adverse events, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome(CES).
- Number of Participants With Symptoms in Follow-Up Questionnaire at 24 Hours [24 hours]
the follow-up questionnaires are foreseen, at 24 h after time of spinal injection (Tsp), to gather all possible neurological adverse events. About 24 h after surgery (indicated as Tsp),Investigator or a deputy will question patients about neurological symptoms and pain not associated to the operation area on the basis of the follow-up questionnaires and giving a score between 0 to 10 to the pain intensity. All other adverse events will also be assessed.
- Number of Participants With Symptoms in Follow-Up Questionnaire at 7 Days [7 days]
the follow-up questionnaires are foreseen, at 7 days after time of spinal injection (Tsp), to gather all possible neurological adverse events. About 7 days after surgery (indicated as Tsp),Investigator or a deputy will question patients about neurological symptoms and pain not associated to the operation area on the basis of the follow-up questionnaires and giving a score between 0 to 10 to the pain intensity. All other adverse events will also be assessed.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male/female adult patients
-
Ability to comprehend the full nature and purpose of the study
-
Ability to co-operate with the Investigator and to comply with the requirements of the entire study
-
Signed written informed consent of the patients prior to inclusion in the observational study. The signature has to be done before the elective surgery.
-
Spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes.
Exclusion Criteria:
-
Hypersensitivity to the active substance, medicinal products of the PABA (para-aminobenzoic acid) ester group, other ester-type local anaesthetics or to any of the excipients (Hydrochloric acid 1N for pH adjustment, Sodium chloride, Water for injection)
-
General and specific contra-indications to spinal anaesthesia regardless of the local anaesthetic used, should be taken into account (e.g. decompensated cardiac insufficiency, hypovolemic shock….)
-
Intravenous regional anaesthesia (the anesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area)
-
Serious problems with cardiac conduction,
-
Severe anaemia,
-
It is also necessary to take into consideration general and specific contraindications for the technique of spinal anaesthesia = intrathecal anaesthesia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anesthesiology and Critical Care Medicine-Hospital AZ Sint Jozef | Malle | Belgium | 2390 |
Sponsors and Collaborators
- Sintetica SA
- Sintesi Research Srl
Investigators
- Principal Investigator: Guido Fanelli, MD, Azienda Ospedaliera di Parma Dipartimento di Anestesia, Rianimazione e Terapia Antalgica - Italy
- Principal Investigator: Capdevila Xavier, MD, Head of the Department of Anesthesiology and Critical Care Medicine of Lapeyronie, France
- Principal Investigator: Stefano Bonarelli, MD, Rizzoli Hospital, Bologna - Italy
- Principal Investigator: John Van Delft, MD, Department of Anesthesiology and Critical Care Medicine, Belgium
- Principal Investigator: Holger Sauer, MD, Klinik für Anästhesie, Intensivmedizin und Schmerztherapie
- Principal Investigator: Martin Bauer, MD, Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin Berufsgenossenschaftliches
- Principal Investigator: Laurent Delaunay, MD, Clinique générale d'Annency - La consultation d'Anesthésie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHL1/01-2012/M
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Chloroprocaine 1% |
|---|---|
| Arm/Group Description | Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes. |
| Period Title: Overall Study | |
| STARTED | 394 |
| COMPLETED | 387 |
| NOT COMPLETED | 7 |
Baseline Characteristics
| Arm/Group Title | Chloroprocaine 1% |
|---|---|
| Arm/Group Description | intrathecal anesthesia with 1% solution of 2-chloroprocaine hydrochloride in patients undergoing short surgical procedures (max. 40 minutes). |
| Overall Participants | 393 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
51.5
(15.4)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
158
40.2%
|
| Male |
235
59.8%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
388
98.7%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
5
1.3%
|
| Region of Enrollment (participants) [Number] | |
| Belgium |
200
50.9%
|
| Germany |
139
35.4%
|
| France |
54
13.7%
|
| BMI (kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg/m^2] |
27.4
(5)
|
Outcome Measures
| Title | Number of Participants With Adverse Events |
|---|---|
| Description | Number of Participants with neurological adverse events, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome(CES). |
| Time Frame | assessed at 24h and 7(-1/+2) days after surgery, total reported |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Chloroprocaine 1% |
|---|---|
| Arm/Group Description | Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes. |
| Measure Participants | 393 |
| 24 hours |
9
2.3%
|
| 7 days |
5
1.3%
|
| Title | Number of Participants With Symptoms in Follow-Up Questionnaire at 24 Hours |
|---|---|
| Description | the follow-up questionnaires are foreseen, at 24 h after time of spinal injection (Tsp), to gather all possible neurological adverse events. About 24 h after surgery (indicated as Tsp),Investigator or a deputy will question patients about neurological symptoms and pain not associated to the operation area on the basis of the follow-up questionnaires and giving a score between 0 to 10 to the pain intensity. All other adverse events will also be assessed. |
| Time Frame | 24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Chloroprocaine 1% |
|---|---|
| Arm/Group Description | intrathecal anesthesia with 1% solution of 2-chloroprocaine hydrochloride in patients undergoing short surgical procedures (max. 40 minutes). |
| Measure Participants | 393 |
| fatigue |
4
|
| nausea/vomiting |
3
|
| dizziness |
1
|
| urin/defec problems |
1
|
| Title | Number of Participants With Symptoms in Follow-Up Questionnaire at 7 Days |
|---|---|
| Description | the follow-up questionnaires are foreseen, at 7 days after time of spinal injection (Tsp), to gather all possible neurological adverse events. About 7 days after surgery (indicated as Tsp),Investigator or a deputy will question patients about neurological symptoms and pain not associated to the operation area on the basis of the follow-up questionnaires and giving a score between 0 to 10 to the pain intensity. All other adverse events will also be assessed. |
| Time Frame | 7 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Chloroprocaine 1% |
|---|---|
| Arm/Group Description | intrathecal anesthesia with 1% solution of 2-chloroprocaine hydrochloride in patients undergoing short surgical procedures (max. 40 minutes). |
| Measure Participants | 393 |
| fatigue |
3
|
| nausea/vomiting |
1
|
| dizziness |
1
|
| urin/defec problems |
2
|
Adverse Events
| Time Frame | 7 days | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Chloroprocaine 1% | |
| Arm/Group Description | Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes. | |
All Cause Mortality |
||
| Chloroprocaine 1% | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/393 (0%) | |
Serious Adverse Events |
||
| Chloroprocaine 1% | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/393 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Chloroprocaine 1% | ||
| Affected / at Risk (%) | # Events | |
| Total | 37/393 (9.4%) | |
| Cardiac disorders | ||
| bradycardia | 4/393 (1%) | 4 |
| Gastrointestinal disorders | ||
| vomiting | 2/393 (0.5%) | 2 |
| General disorders | ||
| drug effect incomplete | 4/393 (1%) | 4 |
| drug ineffective | 1/393 (0.3%) | 1 |
| injection site pain | 1/393 (0.3%) | 1 |
| Injury, poisoning and procedural complications | ||
| anesthetic complication | 3/393 (0.8%) | 3 |
| Incision site haemorrhage | 1/393 (0.3%) | 1 |
| incision site pain | 1/393 (0.3%) | 1 |
| Post lumbar puncture syndrome | 6/393 (1.5%) | 6 |
| Procedural hypotension | 1/393 (0.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| myalgia | 1/393 (0.3%) | 1 |
| Nervous system disorders | ||
| burning sensation | 1/393 (0.3%) | 1 |
| headache | 1/393 (0.3%) | 1 |
| Hypoaesthesia | 2/393 (0.5%) | 2 |
| hypotonia | 2/393 (0.5%) | 2 |
| paresthesia | 4/393 (1%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||
| hyprventilation | 1/393 (0.3%) | 1 |
| Vascular disorders | ||
| hypotension | 13/393 (3.3%) | 13 |
Limitations/Caveats
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 |
- CHL1/01-2012/M