Retroclavicular Versus Supraclavicular Brachial Plexus Block for Hand and Forearm Surgery

May 8, 2018 updated by: Sina Grape, Hôpital du Valais

The Efficacy of Retroclavicular Versus Supraclavicular Brachial Plexus Block in Patients Undergoing Forearm and Hand Surgery: a Randomized Controlled Double-blinded Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Sion, Switzerland, 1950
        • Hopital du Valais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: supraclavicular
patients receive a supraclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 %
Procedure: supraclavicular block
supraclavicular block for forearm or hand surgery
EXPERIMENTAL: 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 %
Procedure: retroclavicular block
retroclavicular block for forearm or hand surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate (loss of sensation to pinprick in the forearm and hand)
Time Frame: 30 minutes after the injection
30 minutes after the injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Needling time in seconds
Time Frame: 15 min
15 min
Time to first analgesic request
Time Frame: 24 hours
24 hours
Block-related complications
Time Frame: 24 hours
24 hours
Postoperative opioid consumption on postoperative day 1
Time Frame: 24 hours
24 hours
Pain scores at 12 hours postoperatively
Time Frame: 12 hours
measured on a visual analogue scale between 0 and 100
12 hours
Pain scores on postoperative day 1
Time Frame: 24 hours
measured on a visual analogue scale between 0 and 100
24 hours
Patient satisfaction as assessed by numerical rating scale
Time Frame: 24 hours
Patient satisfaction on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital du Valais

Investigators

  • Study Director: Eric Albrecht, MD, CHUV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 23, 2015

First Posted (ESTIMATE)

December 29, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCVEM 038/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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