Clinical trial NCT02385097: Chloroprocaine 2% vs Ropivacaine 0.75% in Ultrasound-guided Axillary Nerve Block
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Axillary Nerve Block
Lead sponsor: Sintetica SA
Sponsor class: INDUSTRY
Collaborators: name: Cross S.A.
First posted: 2015-03-11
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Percentage of Participants With Successful Block for Distal Upper Limb Surgeries
timeFrame: 45 min from the time of readiness of surgery
Secondary outcomes:
measure: Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)
timeFrame: Up to 1 h after last perineural injection
measure: Time to Onset of Motor Block
timeFrame: Up to 1 h after last perineural injection
measure: Time to Regression of Sensory Block
timeFrame: Up to 12 hrs after surgery
measure: Time to Regression of Motor Block
timeFrame: Up to 12 hrs after surgery
measure: Partecipants Received Rescue Anaesthesia or Rescue Analgesia
timeFrame: 45 min from the time of readiness of surgery
measure: Number of Subjects Who Received Post-operative Analgesia
timeFrame: From surgery day to 24 hrs post surgery
measure: Time to Eligibility for Home Discharge
timeFrame: from surgery day to 24h post surgery
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: from surgery day to day 6 +/- 1 after surgery
measure: Neurological Symptoms
timeFrame: from surgery day to day 6 +/- 1 after surgery
measure: Heart Rate
timeFrame: from surgery day to 24 hrs post surgery
measure: Blood Pressure
timeFrame: from surgery day to 24 hrs post surgery
measure: SpO2
timeFrame: from surgery day to 24 hrs post surgery
measure: Number of Participants With Normal Electrocardiogram (ECG) Parameters
timeFrame: from surgery day to 24 hrs post surgery
Other outcomes:
Locations:
city: Gravesano
country: Switzerland
facility: Claudio Camponovo
state: Lugano
Study officials:
affiliation: Department of General Anesthesia and Intensive Care Medicine, Spitalgasse 23, 1090 Vienna, Austria
name: Oliver Kimberger, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology,Clinica Ars Medica,Via Cantonale, CH-6929 Gravesano, Switzerland
name: Claudio Camponovo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology, Ospedale Regionale di Bellinzona, CH-6500 Bellinzona, Switzerland
name: Andrea Saporito, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sulyok I, Camponovo C, Zotti O, Haslik W, Kostenberger M, Likar R, Leuratti C, Donati E, Kimberger O. A randomised, non-inferiority study of chloroprocaine 2% and ropivacaine 0.75% in ultrasound-guided axillary block. Sci Rep. 2021 May 11;11(1):10035. doi: 10.1038/s41598-021-89483-y.