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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03378323
Other study ID # BAX Unique
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 1, 2018
Est. completion date April 10, 2019

Study information

Verified date April 2019
Source Hôpital du Valais
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 10, 2019
Est. primary completion date April 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Multiple injection local anesthetic
Multiple injection local anesthetic
Single injection local anesthetic
Single injection local anesthetic

Locations

Country Name City State
Switzerland Hopital du Valais Sion

Sponsors (2)

Lead Sponsor Collaborator
Hôpital du Valais University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance time Time in minutes from ultrasound probe placement to end of local anesthetic injection 10 minutes
Secondary Needling time Time in seconds to complete the block 15 minutes
Secondary Time to first analgesic request Time in minutes to first analgesic request postoperatively 24 hours
Secondary Block-related complications Infection, bleeding, neurological problems, pain during the 24 postoperative hours 24 hours
Secondary Postoperative opioid consumption on postoperative day 1 intravenous morphine equivalent consumption during the 24 postoperative hours 24 hours
Secondary 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
Secondary 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
Secondary Patient satisfaction Assessed by numerical rating scale on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied) 24 hours
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