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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Axillary Nerve Block

Intervention / Treatment
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* Drug: Chloroprocaine HCl 2%
* Drug: Ropivacaine 0.75%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sex and surgery: male and female patients scheduled for short duration (< 60 min) distal upper limb surgery under axillary nerve block anaesthesia Age: ≥ 18 years old Body Mass Index (BMI): 18 - 32 kg/m2 inclusive ASA physical status: I-III Informed consent: signed written informed consent before inclusion in the study 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 peripheral nerve block anaesthesia. History of neuromuscular diseases to the upper extremities Axillary status: Axillary local infections, surgical scarring and pathological lymph node enlargement ASA physical status: IV-V Further anaesthesia: Patients anticipated to be requiring further anaesthesia (general or local anaesthesia) Chronic pain syndromes: Patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents) Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics 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 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 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 Drug, alcohol: history of drug or alcohol abuse Pregnancy: missing or positive pregnancy test at screening, pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 45 min from the time of readiness of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 1 h after last perineural injection | 
| Time to Onset of Motor Block | Time period from completion of the final perineural injection (time 0 h) to achievement of motor block | Up to 1 h after last perineural injection | 
| 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 | Up to 12 hrs after surgery | 
| 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) | Up to 12 hrs after surgery | 
| 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) | 45 min from the time of readiness of surgery | 
| Number of Subjects Who Received Post-operative Analgesia | Number of subjects who received the first post-operative analgesia | From surgery day to 24 hrs post surgery | 
| 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 | from surgery day to 24h post surgery | 
| 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 | from surgery day to day 6 +/- 1 after surgery | 
| Neurological Symptoms | Number of patients with Neurological Symptoms (e.g. paraesthesia, motor function problems and pain at the injection site) | from surgery day to day 6 +/- 1 after surgery | 
| Heart Rate | The following normal ranges Heart Rate parameters will be used: 50-90 beats/min | from surgery day to 24 hrs post surgery | 
| 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 | from surgery day to 24 hrs post surgery | 
| SpO2 | The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95% | from surgery day to 24 hrs post surgery | 
| 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 | from surgery day to 24 hrs post surgery |