Single Versus Multiple Injections for Axillary Plexus Block

Study Overview
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Brief Summary
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Patients will be randomized to one of two groups: Multiple injection group: Axillary brachial plexus block with multiple injections, with the arm abducted, performed with the aid of ultrasound; 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
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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.

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

Conditions
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Upper Extremity

Intervention / Treatment
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* Drug: Multiple injection local anesthetic
* Drug: Single injection local anesthetic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multiple injection local anesthetic<br>Ultrasound guided axillary plexus block with multiple injections of local anesthetic | Drug: Multiple injection local anesthetic<br>* Multiple injection local anesthetic<br>|
| Experimental: Single injection local anesthetic<br>Ultrasound guided axillary plexus block with a single injection of local anesthetic | Drug: Single injection local anesthetic<br>* Single injection local anesthetic<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper extremity surgery