Chloroprocaine 2% vs Ropivacaine 0.75% in Ultrasound-guided Axillary Nerve Block
Condition: Axillary Nerve Block
Intervention: Chloroprocaine HCl 2%; Ropivacaine 0.75%
Intervention description: Single Administration (20mL) by Axillary Nerve Route; Single Administration (20mL) by Axillary Nerve Route
Intervention MeSH terms: Ropivacaine; Chloroprocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 211.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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