Clinical trial NCT03378323: Single Versus Multiple Injections for Axillary Plexus Block
Official title: Single Versus Multiple Injections for Axillary Plexus Block: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper Extremity
Keywords: upper extremity surgery
Lead sponsor: Hôpital du Valais
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2017-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Performance time
timeFrame: 10 minutes
Secondary outcomes:
measure: Needling time
timeFrame: 15 minutes
measure: Time to first analgesic request
timeFrame: 24 hours
measure: Block-related complications
timeFrame: 24 hours
measure: Postoperative opioid consumption on postoperative day 1
timeFrame: 24 hours
measure: Pain scores at 12 hours postoperatively
timeFrame: 12 hours
measure: Pain scores on postoperative day 1
timeFrame: 24 hours
measure: Patient satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Hopital du Valais
Study officials:
affiliation: Hôpital du Valais
name: Sina Grape, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lausanne Hospitals
name: Eric Albrecht, MD
role: STUDY_DIRECTOR
References: