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OpenTrials
Completed

NCT Number: NCT03378323

Single Versus Multiple Injections for Axillary Plexus Block

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital du Valais

Sion, 1950, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiple injection local anesthetic

Drug

Multiple injection local anesthetic

Single injection local anesthetic

Drug

Single injection local anesthetic

Primary outcomes

  1. Performance time

    Time frame: 10 minutes

    Time in minutes from ultrasound probe placement to end of local anesthetic injection

Secondary outcomes

  1. Needling time

    Time frame: 15 minutes

    Time in seconds to complete the block

  2. Time to first analgesic request

    Time frame: 24 hours

    Time in minutes to first analgesic request postoperatively

  3. Block-related complications

    Time frame: 24 hours

    Infection, bleeding, neurological problems, pain during the 24 postoperative hours

  4. Postoperative opioid consumption on postoperative day 1

    Time frame: 24 hours

    intravenous morphine equivalent consumption during the 24 postoperative hours

  5. Pain scores at 12 hours postoperatively

    Time frame: 12 hours

    Measured on a visual analogue scale between 0 and 10 (0 = no pain, 10 = worst pain imaginable)

  6. Pain scores on postoperative day 1

    Time frame: 24 hours

    Measured on a visual analogue scale between 0 and 10 (0 = no pain, 10 = worst pain imaginable)

  7. Patient satisfaction

    Time frame: 24 hours

    Assessed by numerical rating scale on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied)

Sponsors and collaborators

Lead sponsor

Hôpital du Valais

Other

Collaborators

  • University of Lausanne Hospitals

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2017
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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