Title
Chloroprocaine 2% vs Ropivacaine 0.75% in Ultrasound-guided Axillary Nerve Block
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
Phase
Phase 3Lead Sponsor
Sintetica SAStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Axillary Nerve BlockIntervention/Treatment
chloroprocaine ropivacaine ...Study Participants
211The 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.
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
Single Administration (20mL) by Axillary Nerve Route
Single Administration (20mL) by Axillary Nerve Route
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
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
| Event Type | Organ System | Event Term | Chloroprocaine HCl 2% (20 mg/mL) | Ropivacaine 0.75% (7.5 mg/mL) |
|---|
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 period from completion of the final perineural injection (time 0 h) to achievement of sensory block in the 4 nerve territories
Time period from completion of the final perineural injection (time 0 h) to achievement of motor block
Will be deemed to have occurred when cold sensation and sensitive perception have returned (if assessable) in any nerve territory
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 from completion of the final perineural injection (time 0 hour) to administration of first rescue anaesthesia or analgesia (supplementation)
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) occurring or worsening after the first dose of IMP
Number of patients with Neurological Symptoms (e.g. paraesthesia, motor function problems and pain at the injection site)
The following normal ranges Heart Rate parameters will be used: 50-90 beats/min
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
The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95%
Number of subjects who received the first post-operative analgesia
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
