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

Phase 3

Completed

Conditions: Axillary Nerve Block

Interventions: Drug: Ropivacaine 0.75%
Drug: Chloroprocaine HCl 2%

Registration Number: NCT02385097

Lead Sponsor: Sintetica SA

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 211

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine 0.75% (7.5 mg/mL)	Ropivacaine 0.75%	Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
Chloroprocaine HCl 2% (20 mg/mL)	Chloroprocaine HCl 2%	Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL

Primary Outcome Measures

Name	Time	Method
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

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