Chloroprocaine 2% vs Ropivacaine 0.75% in Ultrasound-guided Axillary Nerve Block

• Sponsor: Sintetica SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02385097
• Collaborator: Cross S.A. (Industry)
• Enrollment: 211
• Location: 1
• Arms: 2
• Actual Duration (Months): 25
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief Summary

The Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for distal upper limb surgeries Successful block: anaesthesia adequate for the surgery without any supplementation in the first 45 min.

Condition or Disease	Intervention/Treatment	Phase
Axillary Nerve Block	Drug: Chloroprocaine HCl 2%; Drug: Ropivacaine 0.75%	Phase 3

Detailed Description

This Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for distal upper limb surgeries, without any supplementation in the first 45 min (see definitions below), calculated from the time of readiness for surgery (complete sensory block). Successful block: anaesthesia adequate for the surgery (complete sensory block), without any supplementation in the first 45 min (even if surgery lasts for > 45 min), calculated from the time of readiness for surgery (complete sensory block). Supplementation: i.v. premedication or general anaesthesia or pre- or intra-operative systemic analgesia or additional local anaesthetic infiltration

Study Design

• Study Type: Interventional
• Actual Enrollment: 211 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: A Prospective, Randomised, Non-inferiority Study of Chloroprocaine 2% and the Active Control Ropivacaine 0.75% (AstraZeneca) in Ultrasound-guided Axillary Nerve Block for Short-duration Distal Upper Limb Surgery
• Actual Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chloroprocaine HCl 2% (20 mg/mL) Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL	Drug: Chloroprocaine HCl 2%; Single Administration (20mL) by Axillary Nerve Route; Other Names: Ampres
Active Comparator: Ropivacaine 0.75% (7.5 mg/mL) Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL	Drug: Ropivacaine 0.75%; Single Administration (20mL) by Axillary Nerve Route; Other Names: Naropin

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Successful Block for Distal Upper Limb Surgeries [45 min from the time of readiness of surgery]

   Percentage of patients with a successful block for distal upper limb surgeries, without any supplementation in the first 45 min, calculated from the time of readiness for surgery (complete sensory block).

Secondary Outcome Measures

1. Time to Onset of Sensory Block (Corresponding to Readiness for Surgery) [Up to 1 h after last perineural injection]

   Time period from completion of the final perineural injection (time 0 h) to achievement of sensory block in the 4 nerve territories

2. Time to Onset of Motor Block [Up to 1 h after last perineural injection]

   Time period from completion of the final perineural injection (time 0 h) to achievement of motor block

3. Time to Regression of Sensory Block [Up to 12 hrs after surgery]

   Will be deemed to have occurred when cold sensation and sensitive perception have returned (if assessable) in any nerve territory

4. Time to Regression of Motor Block [Up to 12 hrs after surgery]

   Will be deemed to have occurred when motor score is ≥ 3 (Modified Bromage scale) in any nerve territory (Modified Bromage scale: 0-No movement in relevant muscle group,1-Flicker of movement in relevant muscle group,2-Ability to move relevant muscle group against gravity but inability to move against resistance,3-Reduced power but ability to move muscle group against resistance,4-Full power in relevant muscle group)

5. Partecipants Received Rescue Anaesthesia or Rescue Analgesia [45 min from the time of readiness of surgery]

   partecipants received rescue anaesthesia or rescue analgesia from completion of the final perineural injection (time 0 hour) to administration of first rescue anaesthesia or analgesia (supplementation)

6. Number of Subjects Who Received Post-operative Analgesia [From surgery day to 24 hrs post surgery]

   Number of subjects who received the first post-operative analgesia

7. Time to Eligibility for Home Discharge [from surgery day to 24h post surgery]

   Time from completion of the final perineural injection (time 0 h) to the time when the criteria for discharge are met, even if, according to the hospital procedures, the patient is discharged from the hospital at a later time

8. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [from surgery day to day 6 +/- 1 after surgery]

   Number of Participants with Treatment-emergent Adverse Events (TEAEs) occurring or worsening after the first dose of IMP

9. Neurological Symptoms [from surgery day to day 6 +/- 1 after surgery]

   Number of patients with Neurological Symptoms (e.g. paraesthesia, motor function problems and pain at the injection site)

10. Heart Rate [from surgery day to 24 hrs post surgery]

    The following normal ranges Heart Rate parameters will be used: 50-90 beats/min

11. Blood Pressure [from surgery day to 24 hrs post surgery]

    The following normal ranges Systolic and Diastolic Blood Pressure parameters will be used: Systolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg

12. SpO2 [from surgery day to 24 hrs post surgery]

    The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95%

13. Number of Participants With Normal Electrocardiogram (ECG) Parameters [from surgery day to 24 hrs post surgery]

    Number of Participants with Normal Electrocardiogram (ECG) Parameters. The following normal ranges ECG parameters will be used: Heart Rate: 50-90 beats/min PR Interval: 100-220 msec QRS Duration: ≤ 120 msec QT Interval: ≤ 500 msec

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Sex and surgery: male and female patients scheduled for short duration (< 60 min) distal upper limb surgery under axillary nerve block anaesthesia

2. Age: ≥ 18 years old

3. Body Mass Index (BMI): 18 - 32 kg/m2 inclusive

4. ASA physical status: I-III

5. Informed consent: signed written informed consent before inclusion in the study

6. 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:

1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to peripheral nerve block anaesthesia. History of neuromuscular diseases to the upper extremities

2. Axillary status: Axillary local infections, surgical scarring and pathological lymph node enlargement

3. ASA physical status: IV-V

4. Further anaesthesia: Patients anticipated to be requiring further anaesthesia (general or local anaesthesia)

5. Chronic pain syndromes: Patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents)

6. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics

7. 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 diseases, sepsis, blood coagulation disorders, insulin dependent diabetes mellitus, terminal kidney failure

8. Medications: Medication known to interfere with the extent of regional blocks (see chloroprocaine and ropivacaine SmPCs) for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed

9. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study

10. Drug, alcohol: history of drug or alcohol abuse

11. Pregnancy: missing or positive pregnancy test at screening, pregnant or lactating women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Claudio Camponovo	Gravesano	Lugano	Switzerland	CH-6929

Sponsors and Collaborators

• Sintetica SA
• Cross S.A.

Investigators

• Principal Investigator: Oliver Kimberger, Prof, Department of General Anesthesia and Intensive Care Medicine, Spitalgasse 23, 1090 Vienna, Austria
• Principal Investigator: Claudio Camponovo, MD, Department of Anaesthesiology,Clinica Ars Medica,Via Cantonale, CH-6929 Gravesano, Switzerland
• Principal Investigator: Andrea Saporito, MD, Department of Anaesthesiology, Ospedale Regionale di Bellinzona, CH-6500 Bellinzona, Switzerland

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 17, 2014

More Information

Publications

None provided.

• Responsible Party: Sintetica SA
• ClinicalTrials.gov Identifier: NCT02385097
• Other Study ID Numbers: CHL.2/01-2014/M
• First Posted: Mar 11, 2015
• Last Update Posted: Jul 15, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Ropivacaine; Chloroprocaine

Study Results

Participant Flow

Recruitment Details	From April 2015 to May 2017 in Medical clinic and Hospital

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Period Title: Overall Study
STARTED	106	105
COMPLETED	106	105
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)	Total
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route	Total of all reporting groups
Overall Participants	106	105	211
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.4 (15.4)	52.6 (18.7)	54 (17.1)
Sex: Female, Male (Count of Participants)
Female	71 67%	60 57.1%	131 62.1%
Male	35 33%	45 42.9%	80 37.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 0.9%	3 2.9%	4 1.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	104 98.1%	101 96.2%	205 97.2%
More than one race	1 0.9%	1 1%	2 0.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Austria	62 58.5%	62 59%	124 58.8%
Switzerland	44 41.5%	43 41%	87 41.2%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.58 (3.83)	25.61 (3.55)	25.60 (3.69)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Successful Block for Distal Upper Limb Surgeries
Description	Percentage of patients with a successful block for distal upper limb surgeries, without any supplementation in the first 45 min, calculated from the time of readiness for surgery (complete sensory block).
Time Frame	45 min from the time of readiness of surgery

Outcome Measure Data

Analysis Population Description

211 patients were enrolled in the study. 106 of the enrolled patients were randomised to the Test treatment group and 105 patients to the Reference treatment group. Two subjects, one in the Test and one in the Reference treatment group discontinued the study before treatment (withdrawal by subject). In the Test treatment group, 105 patients were treated and completed the study. In the Reference treatment group, 104 patients were treated, 103 of them completed the study.

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
Count of Participants [Participants]	96 90.6%	97 92.4%

2. Secondary Outcome

Title	Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)
Description	Time period from completion of the final perineural injection (time 0 h) to achievement of sensory block in the 4 nerve territories
Time Frame	Up to 1 h after last perineural injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
Median (95% Confidence Interval) [minutes]	10	15

3. Secondary Outcome

Title	Time to Onset of Motor Block
Description	Time period from completion of the final perineural injection (time 0 h) to achievement of motor block
Time Frame	Up to 1 h after last perineural injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
Median (95% Confidence Interval) [minutes]	10	10

4. Secondary Outcome

Title	Time to Regression of Sensory Block
Description	Will be deemed to have occurred when cold sensation and sensitive perception have returned (if assessable) in any nerve territory
Time Frame	Up to 12 hrs after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
Median (95% Confidence Interval) [minutes]	68	451

5. Secondary Outcome

Title	Time to Regression of Motor Block
Description	Will be deemed to have occurred when motor score is ≥ 3 (Modified Bromage scale) in any nerve territory (Modified Bromage scale: 0-No movement in relevant muscle group,1-Flicker of movement in relevant muscle group,2-Ability to move relevant muscle group against gravity but inability to move against resistance,3-Reduced power but ability to move muscle group against resistance,4-Full power in relevant muscle group)
Time Frame	Up to 12 hrs after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
Median (95% Confidence Interval) [minutes]	65	415

6. Secondary Outcome

Title	Partecipants Received Rescue Anaesthesia or Rescue Analgesia
Description	partecipants received rescue anaesthesia or rescue analgesia from completion of the final perineural injection (time 0 hour) to administration of first rescue anaesthesia or analgesia (supplementation)
Time Frame	45 min from the time of readiness of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
Count of Participants [Participants]	9 8.5%	7 6.7%

7. Secondary Outcome

Title	Number of Subjects Who Received Post-operative Analgesia
Description	Number of subjects who received the first post-operative analgesia
Time Frame	From surgery day to 24 hrs post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
Count of Participants [Participants]	49 46.2%	46 43.8%

8. Secondary Outcome

Title	Time to Eligibility for Home Discharge
Description	Time from completion of the final perineural injection (time 0 h) to the time when the criteria for discharge are met, even if, according to the hospital procedures, the patient is discharged from the hospital at a later time
Time Frame	from surgery day to 24h post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
Median (95% Confidence Interval) [minutes]	161	355.5

9. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description	Number of Participants with Treatment-emergent Adverse Events (TEAEs) occurring or worsening after the first dose of IMP
Time Frame	from surgery day to day 6 +/- 1 after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
Count of Participants [Participants]	58 54.7%	76 72.4%

10. Secondary Outcome

Title	Neurological Symptoms
Description	Number of patients with Neurological Symptoms (e.g. paraesthesia, motor function problems and pain at the injection site)
Time Frame	from surgery day to day 6 +/- 1 after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
burning : discharge	8 7.5%	1 1%
burning : day 7	6 5.7%	4 3.8%
tingling : discharge	8 7.5%	25 23.8%
tingling : day 7	5 4.7%	6 5.7%
Pins and needles sensation : discharge	1 0.9%	5 4.8%
Pins and needles sensation : day 7	2 1.9%	0 0%
Pricking : discharge	8 7.5%	5 4.8%
Pricking : day 7	0 0%	0 0%
aching : discharge	10 9.4%	6 5.7%
aching : day 7	4 3.8%	3 2.9%
numbness : discharge	2 1.9%	27 25.7%
numbness : day 7	2 1.9%	3 2.9%
hypoesthesia : discharge	5 4.7%	14 13.3%
hypoesthesia : day 7	5 4.7%	5 4.8%
Pain surgery site : discharge	0 0%	1 1%
Pain surgery site : day 7	0 0%	0 0%
diffuse hair loss : discharge	0 0%	0 0%
diffuse hair loss : day 7	0 0%	1 1%
headache : discharge	0 0%	0 0%
headache : day 7	2 1.9%	0 0%
itching : discharge	0 0%	0 0%
itching : day 7	0 0%	1 1%

11. Secondary Outcome

Title	Heart Rate
Description	The following normal ranges Heart Rate parameters will be used: 50-90 beats/min
Time Frame	from surgery day to 24 hrs post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
screening	73 (12)	73.6 (12.3)
baseline	72.5 (10.8)	71.6 (12.5)
discharge	71.5 (11.5)	73 (12.3)

12. Secondary Outcome

Title	Blood Pressure
Description	The following normal ranges Systolic and Diastolic Blood Pressure parameters will be used: Systolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg
Time Frame	from surgery day to 24 hrs post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
Systolic Blood Pressure at screening	137 (20.5)	136.2 (18.2)
Systolic Blood Pressure at baseline	136.6 (18.9)	138 (19.1)
Systolic Blood Pressure at discharge	130.5 (17.8)	130.1 (17.3)
Diastolic Blood Pressure at screening	80.8 (11.4)	80.5 (9.8)
Diastolic Blood Pressure at baseline	78.2 (10.7)	80.1 (10.4)
Diastolic Blood Pressure at discharge	74.4 (11.1)	75.4 (9.8)

13. Secondary Outcome

Title	SpO2
Description	The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95%
Time Frame	from surgery day to 24 hrs post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
baseline	97.05 (1.51)	97.36 (1.69)
discharge	97.47 (1.52)	97.61 (1.33)

14. Secondary Outcome

Title	Number of Participants With Normal Electrocardiogram (ECG) Parameters
Description	Number of Participants with Normal Electrocardiogram (ECG) Parameters. The following normal ranges ECG parameters will be used: Heart Rate: 50-90 beats/min PR Interval: 100-220 msec QRS Duration: ≤ 120 msec QT Interval: ≤ 500 msec
Time Frame	from surgery day to 24 hrs post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)	Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
Measure Participants	105	104
Count of Participants [Participants]	105 99.1%	104 99%

Adverse Events

Time Frame	7 days
Arm/Group Title	Chloroprocaine HCl 2% (20 mg/mL)		Ropivacaine 0.75% (7.5 mg/mL)
Arm/Group Description	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route		Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route
All Cause Mortality
	Chloroprocaine HCl 2% (20 mg/mL)		Ropivacaine 0.75% (7.5 mg/mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/106 (0%)		0/105 (0%)
Serious Adverse Events
	Chloroprocaine HCl 2% (20 mg/mL)		Ropivacaine 0.75% (7.5 mg/mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/106 (0%)		0/105 (0%)
Other (Not Including Serious) Adverse Events
	Chloroprocaine HCl 2% (20 mg/mL)		Ropivacaine 0.75% (7.5 mg/mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	58/106 (54.7%)		76/105 (72.4%)
Gastrointestinal disorders
nausea	1/106 (0.9%)	1	4/105 (3.8%)	4
General disorders
injection site pain	6/106 (5.7%)	6	5/105 (4.8%)	5
Injury, poisoning and procedural complications
Procedural pain	48/106 (45.3%)	50	41/105 (39%)	43
Musculoskeletal and connective tissue disorders
pain in extremity	11/106 (10.4%)	12	5/105 (4.8%)	5
Nervous system disorders
Hypoaestesia	9/106 (8.5%)	10	38/105 (36.2%)	44
Paraestesia	17/106 (16%)	22	28/105 (26.7%)	40
burning sensation	11/106 (10.4%)	11	5/105 (4.8%)	5
headache	3/106 (2.8%)	3	1/105 (1%)	1
sensorimotor disorder	0/106 (0%)	0	1/105 (1%)	1
Skin and subcutaneous tissue disorders
Alopecia	0/106 (0%)	0	1/105 (1%)	1
erythema	0/106 (0%)	0	1/105 (1%)	1
pruritus	0/106 (0%)	0	1/105 (1%)	1
Vascular disorders
Hypotension	0/106 (0%)	0	1/105 (1%)	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.