Single Versus Multiple Injections for Axillary Plexus Block

NCT ID: NCT03378323

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-04-10

Brief Summary

Patients will be randomized to one of two groups:

1. Multiple injection group: Axillary brachial plexus block with multiple injections, with the arm abducted, performed with the aid of ultrasound;

2. Single injection group: Axillary brachial plexus block with a single injection, with the arm placed behind the head and the elbow flexed, performed with the aid of ultrasound

Detailed Description

The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups The first group - multiple injection group - will receive an ultrasound-guided axillary brachial plexus block with the traditional technique, i.e. multiple injections of local anesthetic in proximity to the 4 nerfs that innervate the arm. The arm will be abducted during the block procedure.

The second group - single injection group - will receive an ultrasound-guided axillary brachial plexus block with the arm placed behind the head and the elbow flexed. In this position the different nerfs group around the axillary artery where they will be blocked with a single injection of local anesthetic.

All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %.

The primary outcome measure is the time needed for the performance of the block. Secondary outcomes are: success rate of the block at 30 minutes after the injection, needling time, time to first analgesic request, postoperative opioid consumption, pain scores at 12 and 24 hours postoperatively, block-related complications, and patient satisfaction. These outcomes are further defined in the section below.

Conditions

Upper Extremity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multiple injection local anesthetic

Ultrasound guided axillary plexus block with multiple injections of local anesthetic

Group Type: ACTIVE_COMPARATOR

Multiple injection local anesthetic

Intervention Type: DRUG

Multiple injection local anesthetic

Single injection local anesthetic

Ultrasound guided axillary plexus block with a single injection of local anesthetic

Group Type: EXPERIMENTAL

Single injection local anesthetic

Intervention Type: DRUG

Single injection local anesthetic

Interventions

Multiple injection local anesthetic

Multiple injection local anesthetic

Intervention Type: DRUG

Single injection local anesthetic

Single injection local anesthetic

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients who undergo forearm or hand surgery under axillary 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

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

Hôpital du Valais

OTHER

Sponsor Role: lead

Responsible Party

Sina Grape

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sina Grape, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital du Valais

Eric Albrecht, MD

Role: STUDY_DIRECTOR

University of Lausanne Hospitals

Locations

Hopital du Valais

Sion, , Switzerland

Countries

Switzerland

Other Identifiers

BAX Unique

Identifier Type: -

Identifier Source: org_study_id