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

NCT ID: NCT04046744

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-07

Study Completion Date

2022-09-15

Brief Summary

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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

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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

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Wrist Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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BAX

Group Type ACTIVE_COMPARATOR

Axillary brachial plexus block with a long-acting local anesthetic

Intervention Type PROCEDURE

axillary block with 15-30 ml Ropivacaine 0,5%.

Ropivacaine

Intervention Type DRUG

axillary block with 15-30 ml Ropivacaine 0,5%

BAX-Asso

Group Type EXPERIMENTAL

Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic

Intervention Type PROCEDURE

axillary block with 15-30 ml Lidocaine 1,5% + radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%.

Ropivacaine

Intervention Type DRUG

radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%

Lidocaine

Intervention Type DRUG

axillary block with 15-30 ml Lidocaine 1,5%

Interventions

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Axillary brachial plexus block with a long-acting local anesthetic

axillary block with 15-30 ml Ropivacaine 0,5%.

Intervention Type PROCEDURE

Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic

axillary block with 15-30 ml Lidocaine 1,5% + radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%.

Intervention Type PROCEDURE

Ropivacaine

axillary block with 15-30 ml Ropivacaine 0,5%

Intervention Type DRUG

Ropivacaine

radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%

Intervention Type DRUG

Lidocaine

axillary block with 15-30 ml Lidocaine 1,5%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing wrist fracture surgery under regional anesthesia
* Consent for participation
* Affiliation to the French social security system

Exclusion Criteria

* Chronic use of opiod analgesics
* Chronic pain syndrome or fibromyalgia
* Contraindication for locoregional anesthesia
* Contraindication for opioid
* ASA IV
* Pregnant or breastfeeding women
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
* Communication difficulties or neuropsychiatric disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CMC Ambroise Paré

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique du Pré

Le Mans, Pays de la Loire Region, France

Site Status

Hôpital Privé Paul D'Egine

Champigny-sur-Marne, Île-de-France Region, France

Site Status

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, France

Site Status

Hôpital Privé Armand Brillard

Nogent-sur-Marne, Île-de-France Region, France

Site Status

Clinique Bizet

Paris, Île-de-France Region, France

Site Status

Clinique Jouvenet

Paris, Île-de-France Region, France

Site Status

Clinique Rémusat

Paris, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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2019/03

Identifier Type: -

Identifier Source: org_study_id

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