Retroclavicular Versus Supraclavicular Brachial Plexus Block for Hand and Forearm Surgery

Hand Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641613
• Other study ID #: CCVEM 038/15
• Status: Completed
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Hôpital du Valais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hand Injuries
• Hand Injury

Intervention

Procedure:
• retroclavicular block
retroclavicular block for forearm or hand surgery
• supraclavicular block
supraclavicular block for forearm or hand surgery

Locations

Country	Name	City	State
Switzerland	Hopital du Valais	Sion

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital du Valais

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate (loss of sensation to pinprick in the forearm and hand)		30 minutes after the injection
Secondary	Needling time in seconds		15 min
Secondary	Time to first analgesic request		24 hours
Secondary	Block-related complications		24 hours
Secondary	Postoperative opioid consumption on postoperative day 1		24 hours
Secondary	Pain scores at 12 hours postoperatively	measured on a visual analogue scale between 0 and 100	12 hours
Secondary	Pain scores on postoperative day 1	measured on a visual analogue scale between 0 and 100	24 hours
Secondary	Patient satisfaction as assessed by numerical rating scale	Patient satisfaction on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied)	24 hours