Single Versus Multiple Injections for Axillary Plexus Block

Single Versus Multiple Injections for Axillary Plexus Block: a Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Upper Extremity
• Intervention / Treatment: Drug: Multiple injection local anesthetic; Drug: Single injection local anesthetic

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Sion, Switzerland, 1950
    • Hôpital du Valais

Participation Criteria

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 axillary brachial plexus block

Exclusion Criteria:

• History of allergic reaction to local anaesthetics
• Peripheral neuropathy
• Renal or hepatic insufficiency
• Coagulation disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Multiple injection local anesthetic; Ultrasound guided axillary plexus block with multiple injections of local anesthetic	Drug: Multiple injection local anesthetic; Multiple injection local anesthetic
Experimental: Single injection local anesthetic; Ultrasound guided axillary plexus block with a single injection of local anesthetic	Drug: Single injection local anesthetic; Single injection local anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance time	Time in minutes from ultrasound probe placement to end of local anesthetic injection	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needling time	Time in seconds to complete the block	15 minutes
Time to first analgesic request	Time in minutes to first analgesic request postoperatively	24 hours
Block-related complications	Infection, bleeding, neurological problems, pain during the 24 postoperative hours	24 hours
Postoperative opioid consumption on postoperative day 1	intravenous morphine equivalent consumption during the 24 postoperative hours	24 hours
Pain scores at 12 hours postoperatively	Measured on a visual analogue scale between 0 and 10 (0 = no pain, 10 = worst pain imaginable)	12 hours
Pain scores on postoperative day 1	Measured on a visual analogue scale between 0 and 10 (0 = no pain, 10 = worst pain imaginable)	24 hours
Patient satisfaction	Assessed by numerical rating scale on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied)	24 hours

Collaborators and Investigators

• Sponsor: Hôpital du Valais
• Collaborators: University of Lausanne Hospitals
• Investigators: Study Director: Eric Albrecht, MD, Lausanne University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): April 9, 2019
• Study Completion (Actual): April 10, 2019

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: upper extremity surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: BAX Unique

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No