Clinical Trials Directory

Trials / Completed

CompletedNCT04046744

Axillary Block in Association With Analgesic Truncal Blocks at the Elbow for Wrist Surgery.

Axillary Block in Association With Analgesic Truncal Blocks of the Median and Radial Nerves at the Elbow for Wrist Surgery.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
150 (actual)
Sponsor
CMC Ambroise Paré · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Fractures of the forearm bones that occur around the wrist are common in the elderly. Standard anesthesia for its surgical treatment is regional anesthesia (RA): supraclavicular block, infraclavicular block or axillary block (BAX). However, these techniques have some limitations, such as the postoperative pain management and the non-specificity of the analgesia. Indeed analgesia is not specific to the wrist and extends to the elbow and forearm, preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic (LA) is used. Recently RA techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective: good anesthesia for surgery and specific analgesia. The hypothesis of this study is that, for the wrist surgery, axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction, an optimal surgical comfort, a longer post-operative analgesia duration and a faster recovery from motor block.

Detailed description

This multicenter, prospective, randomized, open-Label study compares two techniques : * BAX (usual technique) : Axillary brachial plexus block (Axillary block) with a long-acting LA (Ropivacaine) * BAX-Asso (experimental technique) : Axillary brachial plexus block (Axillary block) with a short-acting local anesthetic (Lidocaine) + Analgesic block at the elbow with a long-acting local anesthetic (Ropivacaine) Every block will be performed under Ultrasound. BAX will be performed using a multi-injection technique at contact with median (nM), radial (nR), ulnar (nU), musculocutaneous (nMC) and medial antebrachial cutaneous (nCMAB) nerves. 15-30 mL of LA will be injected. Analgesic truncal blocks of the median and radial nerves will be performed at the elbow. 3-7 mL of LA will be injected.

Conditions

Interventions

TypeNameDescription
PROCEDUREAxillary brachial plexus block with a long-acting local anestheticaxillary block with 15-30 ml Ropivacaine 0,5%.
PROCEDUREAxillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anestheticaxillary block with 15-30 ml Lidocaine 1,5% + radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%.
DRUGRopivacaineaxillary block with 15-30 ml Ropivacaine 0,5%
DRUGRopivacaineradial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%
DRUGLidocaineaxillary block with 15-30 ml Lidocaine 1,5%

Timeline

Start date
2019-10-07
Primary completion
2022-09-01
Completion
2022-09-15
First posted
2019-08-06
Last updated
2022-09-22

Locations

7 sites across 1 country: France

Source: ClinicalTrials.gov record NCT04046744. Inclusion in this directory is not an endorsement.