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

NCT ID: NCT02385097

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-05-31

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

Conditions

Axillary Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Chloroprocaine HCl 2% (20 mg/mL)

Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL

Group Type: EXPERIMENTAL

Chloroprocaine HCl 2%

Intervention Type: DRUG

Single Administration (20mL) by Axillary Nerve Route

Ropivacaine 0.75% (7.5 mg/mL)

Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.75%

Intervention Type: DRUG

Single Administration (20mL) by Axillary Nerve Route

Interventions

Chloroprocaine HCl 2%

Single Administration (20mL) by Axillary Nerve Route

Intervention Type: DRUG

Ropivacaine 0.75%

Single Administration (20mL) by Axillary Nerve Route

Intervention Type: DRUG

Other Intervention Names

Ampres; Naropin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cross S.A.

INDUSTRY

Sponsor Role: collaborator

Sintetica SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Kimberger, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of General Anesthesia and Intensive Care Medicine, Spitalgasse 23, 1090 Vienna, Austria

Claudio Camponovo, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology,Clinica Ars Medica,Via Cantonale, CH-6929 Gravesano, Switzerland

Andrea Saporito, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, Ospedale Regionale di Bellinzona, CH-6500 Bellinzona, Switzerland

Locations

Claudio Camponovo

Gravesano, Lugano, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 33976374 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CHL.2/01-2014/M

Identifier Type: -

Identifier Source: org_study_id