Retroclavicular Versus Supraclavicular Brachial Plexus Block for Hand and Forearm Surgery

NCT ID: NCT02641613

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-05-31

Brief Summary

Patients will be randomized to one of two groups:

1. Supraclavicular group: supraclavicular brachial plexus block performed with the aid of ultrasound;

2. Retroclavicular group: retroclavicular brachial plexus block performed with the aid of ultrasound.

Detailed Description

The study will be proposed to all patients undergoing formarm or hand surgery under brachial plexus block. Patients will be randomized to one of two groups The first group - supraclavicular group - will receive an ultrasound-guided brachial plexus block via the supraclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. The second group - retroclavicular group - will receive an ultrasound-guided brachial plexus block via the retroclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. Primary outcome is success rate at 30 minutes after the injection defined as loss of sensation to pinprick in the forearm and hand. Secondary outcomes are: needling time, time to first analgesic request, postoperative opioid consumption, pain scores at 12 and 24 hours postoperatively, block-related complications, and patient satisfaction.

Conditions

Hand Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

supraclavicular

patients receive a supraclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 %

Group Type: ACTIVE_COMPARATOR

supraclavicular block

Intervention Type: PROCEDURE

supraclavicular block for forearm or hand surgery

retroclavicular block

patients receive a retroclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 %

Group Type: EXPERIMENTAL

retroclavicular block

Intervention Type: PROCEDURE

retroclavicular block for forearm or hand surgery

Interventions

retroclavicular block

retroclavicular block for forearm or hand surgery

Intervention Type: PROCEDURE

supraclavicular block

supraclavicular block for forearm or hand surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adult patients who undergo forearm or hand surgery under brachial plexus block.

Exclusion Criteria

• History of allergic reaction to local anaesthetics

• Peripheral neuropathy
• Renal or hepatic insufficiency
• Coagulation disorders

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

Sponsors

Hôpital du Valais

OTHER

Sponsor Role: lead

Responsible Party

Sina Grape

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sina Grape, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital du Valais

Eric Albrecht, MD

Role: STUDY_DIRECTOR

CHUV

Locations

Hopital du Valais

Sion, , Switzerland

Countries

Switzerland

References

Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.

Reference Type: DERIVED

PMID: 30857608 (View on PubMed)

Other Identifiers

CCVEM 038/15

Identifier Type: -

Identifier Source: org_study_id