Axillary Nerve Block
Conditions
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.
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
Interventions
DRUGChloroprocaine HCl 2%
Single Administration (20mL) by Axillary Nerve Route
Single Administration (20mL) by Axillary Nerve Route
Sponsors
Cross S.A.
Sintetica SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | from surgery day to 24 hrs post surgery | The following normal ranges Heart Rate parameters will be used: 50-90 beats/min |
| 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 |
| 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 |
| 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 |
| 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) |
| 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) |
| 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) |
| 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 |
| 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 |
| 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 |
| SpO2 | from surgery day to 24 hrs post surgery | The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95% |
| 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 |
| 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 |
Countries
Switzerland
Participant flow
Recruitment details
From April 2015 to May 2017 in Medical clinic and Hospital
Participants by arm
| Arm | Count |
|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2%: Single Administration (20mL) by Axillary Nerve Route | 106 |
| Ropivacaine 0.75% (7.5 mg/mL) Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75%: Single Administration (20mL) by Axillary Nerve Route | 105 |
| Total | 211 |
Baseline characteristics
| Characteristic | Chloroprocaine HCl 2% (20 mg/mL) | Ropivacaine 0.75% (7.5 mg/mL) | Total |
|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 15.4 | 52.6 years STANDARD_DEVIATION 18.7 | 54 years STANDARD_DEVIATION 17.1 |
| Body Mass Index | 25.58 kg/m^2 STANDARD_DEVIATION 3.83 | 25.61 kg/m^2 STANDARD_DEVIATION 3.55 | 25.60 kg/m^2 STANDARD_DEVIATION 3.69 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 104 Participants | 101 Participants | 205 Participants |
| Region of Enrollment Austria | 62 Participants | 62 Participants | 124 Participants |
| Region of Enrollment Switzerland | 44 Participants | 43 Participants | 87 Participants |
| Sex: Female, Male Female | 71 Participants | 60 Participants | 131 Participants |
| Sex: Female, Male Male | 35 Participants | 45 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 106 | 0 / 105 |
| other Total, other adverse events | 58 / 106 | 76 / 105 |
| serious Total, serious adverse events | 0 / 106 | 0 / 105 |
Outcome results
Primary
Percentage of Participants With Successful Block for Distal Upper Limb Surgeries
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Percentage of Participants With Successful Block for Distal Upper Limb Surgeries | 96 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Percentage of Participants With Successful Block for Distal Upper Limb Surgeries | 97 Participants |
Secondary
Blood Pressure
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Blood Pressure | Systolic Blood Pressure at discharge | 130.5 mmHg | Standard Deviation 17.8 |
| Chloroprocaine HCl 2% (20 mg/mL) | Blood Pressure | Diastolic Blood Pressure at baseline | 78.2 mmHg | Standard Deviation 10.7 |
| Chloroprocaine HCl 2% (20 mg/mL) | Blood Pressure | Diastolic Blood Pressure at screening | 80.8 mmHg | Standard Deviation 11.4 |
| Chloroprocaine HCl 2% (20 mg/mL) | Blood Pressure | Systolic Blood Pressure at baseline | 136.6 mmHg | Standard Deviation 18.9 |
| Chloroprocaine HCl 2% (20 mg/mL) | Blood Pressure | Diastolic Blood Pressure at discharge | 74.4 mmHg | Standard Deviation 11.1 |
| Chloroprocaine HCl 2% (20 mg/mL) | Blood Pressure | Systolic Blood Pressure at screening | 137 mmHg | Standard Deviation 20.5 |
| Ropivacaine 0.75% (7.5 mg/mL) | Blood Pressure | Diastolic Blood Pressure at discharge | 75.4 mmHg | Standard Deviation 9.8 |
| Ropivacaine 0.75% (7.5 mg/mL) | Blood Pressure | Systolic Blood Pressure at screening | 136.2 mmHg | Standard Deviation 18.2 |
| Ropivacaine 0.75% (7.5 mg/mL) | Blood Pressure | Systolic Blood Pressure at baseline | 138 mmHg | Standard Deviation 19.1 |
| Ropivacaine 0.75% (7.5 mg/mL) | Blood Pressure | Systolic Blood Pressure at discharge | 130.1 mmHg | Standard Deviation 17.3 |
| Ropivacaine 0.75% (7.5 mg/mL) | Blood Pressure | Diastolic Blood Pressure at baseline | 80.1 mmHg | Standard Deviation 10.4 |
| Ropivacaine 0.75% (7.5 mg/mL) | Blood Pressure | Diastolic Blood Pressure at screening | 80.5 mmHg | Standard Deviation 9.8 |
Secondary
Heart Rate
The following normal ranges Heart Rate parameters will be used: 50-90 beats/min
Time frame: from surgery day to 24 hrs post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Heart Rate | screening | 73 beats/minutes | Standard Deviation 12 |
| Chloroprocaine HCl 2% (20 mg/mL) | Heart Rate | baseline | 72.5 beats/minutes | Standard Deviation 10.8 |
| Chloroprocaine HCl 2% (20 mg/mL) | Heart Rate | discharge | 71.5 beats/minutes | Standard Deviation 11.5 |
| Ropivacaine 0.75% (7.5 mg/mL) | Heart Rate | screening | 73.6 beats/minutes | Standard Deviation 12.3 |
| Ropivacaine 0.75% (7.5 mg/mL) | Heart Rate | baseline | 71.6 beats/minutes | Standard Deviation 12.5 |
| Ropivacaine 0.75% (7.5 mg/mL) | Heart Rate | discharge | 73 beats/minutes | Standard Deviation 12.3 |
Secondary
Neurological Symptoms
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | numbness : day 7 | 2 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | Pricking : discharge | 8 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | hypoesthesia : discharge | 5 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | burning : day 7 | 6 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | hypoesthesia : day 7 | 5 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | Pricking : day 7 | 0 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | Pain surgery site : discharge | 0 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | tingling : day 7 | 5 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | Pain surgery site : day 7 | 0 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | aching : discharge | 10 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | diffuse hair loss : discharge | 0 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | Pins and needles sensation : day 7 | 2 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | diffuse hair loss : day 7 | 0 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | aching : day 7 | 4 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | headache : discharge | 0 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | Pins and needles sensation : discharge | 1 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | headache : day 7 | 2 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | numbness : discharge | 2 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | itching : discharge | 0 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | tingling : discharge | 8 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | itching : day 7 | 0 Participants |
| Chloroprocaine HCl 2% (20 mg/mL) | Neurological Symptoms | burning : discharge | 8 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | itching : day 7 | 1 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | Pins and needles sensation : day 7 | 0 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | burning : discharge | 1 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | burning : day 7 | 4 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | tingling : discharge | 25 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | tingling : day 7 | 6 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | Pins and needles sensation : discharge | 5 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | Pricking : discharge | 5 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | Pricking : day 7 | 0 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | aching : discharge | 6 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | aching : day 7 | 3 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | numbness : discharge | 27 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | numbness : day 7 | 3 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | hypoesthesia : discharge | 14 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | hypoesthesia : day 7 | 5 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | Pain surgery site : discharge | 1 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | Pain surgery site : day 7 | 0 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | diffuse hair loss : discharge | 0 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | diffuse hair loss : day 7 | 1 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | headache : discharge | 0 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | headache : day 7 | 0 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Neurological Symptoms | itching : discharge | 0 Participants |
Secondary
Number of Participants With Normal Electrocardiogram (ECG) Parameters
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Number of Participants With Normal Electrocardiogram (ECG) Parameters | 105 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Number of Participants With Normal Electrocardiogram (ECG) Parameters | 104 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 58 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 76 Participants |
Secondary
Number of Subjects Who Received Post-operative Analgesia
Number of subjects who received the first post-operative analgesia
Time frame: From surgery day to 24 hrs post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Number of Subjects Who Received Post-operative Analgesia | 49 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Number of Subjects Who Received Post-operative Analgesia | 46 Participants |
Secondary
Partecipants Received Rescue Anaesthesia or Rescue Analgesia
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Partecipants Received Rescue Anaesthesia or Rescue Analgesia | 9 Participants |
| Ropivacaine 0.75% (7.5 mg/mL) | Partecipants Received Rescue Anaesthesia or Rescue Analgesia | 7 Participants |
Secondary
SpO2
The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95%
Time frame: from surgery day to 24 hrs post surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | SpO2 | baseline | 97.05 percentage of SpO2 | Standard Deviation 1.51 |
| Chloroprocaine HCl 2% (20 mg/mL) | SpO2 | discharge | 97.47 percentage of SpO2 | Standard Deviation 1.52 |
| Ropivacaine 0.75% (7.5 mg/mL) | SpO2 | baseline | 97.36 percentage of SpO2 | Standard Deviation 1.69 |
| Ropivacaine 0.75% (7.5 mg/mL) | SpO2 | discharge | 97.61 percentage of SpO2 | Standard Deviation 1.33 |
Secondary
Time to Eligibility for Home Discharge
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Time to Eligibility for Home Discharge | 161 minutes |
| Ropivacaine 0.75% (7.5 mg/mL) | Time to Eligibility for Home Discharge | 355.5 minutes |
Secondary
Time to Onset of Motor Block
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Time to Onset of Motor Block | 10 minutes |
| Ropivacaine 0.75% (7.5 mg/mL) | Time to Onset of Motor Block | 10 minutes |
Secondary
Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Time to Onset of Sensory Block (Corresponding to Readiness for Surgery) | 10 minutes |
| Ropivacaine 0.75% (7.5 mg/mL) | Time to Onset of Sensory Block (Corresponding to Readiness for Surgery) | 15 minutes |
Secondary
Time to Regression of Motor Block
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Time to Regression of Motor Block | 65 minutes |
| Ropivacaine 0.75% (7.5 mg/mL) | Time to Regression of Motor Block | 415 minutes |
Secondary
Time to Regression of Sensory Block
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chloroprocaine HCl 2% (20 mg/mL) | Time to Regression of Sensory Block | 68 minutes |
| Ropivacaine 0.75% (7.5 mg/mL) | Time to Regression of Sensory Block | 451 minutes |