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

Wrist Fracture Clinical Trial

— BAXASSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04046744
• Other study ID #: 2019/03
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: September 15, 2022

Study information

• Verified date: September 2022
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 15, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wrist Fracture

Intervention

Procedure:
• Axillary brachial plexus block with a long-acting local anesthetic
axillary block with 15-30 ml Ropivacaine 0,5%.
• 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%.

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

Locations

Country	Name	City	State
France	Hôpital Privé Paul D'Egine	Champigny-sur-Marne	Ile-de-France
France	Clinique du Pré	Le Mans	Pays De La Loire
France	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France
France	Hôpital Privé Armand Brillard	Nogent-sur-Marne	Ile-de-France
France	Clinique Bizet	Paris	Ile-de -France
France	Clinique Jouvenet	Paris	Ile-de-France
France	Clinique Rémusat	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of pain when the patient recovers the flexion of the forearm on the arm	Pain VRS ranging from 0 to 10 (0=no pain, 10=worst possible pain)	24 hours
Secondary	Duration of motor block at the elbow	Time between the performance of regional anesthesia and the elbow flexion recovery	24 hours
Secondary	Axillary block success	Assess of motor block and sensory perception to pin-prick in the distribution of the five terminal branches at 10, 20, and 30 minutes postinjection.; Motor block: complete (2=paralysis), partial (1=paresis), or none (0). Motor function assessed in the following manner: wrist and finger flexion (median nerve), wrist and finger extension (radial nerve), thumb adduction and flexor carpi ulnaris flexion (ulnar nerve), and biceps flexion (musculocutaneous nerve).; Sensory block: complete/anesthesia (2=loss of sensation to pinprick), partial/analgesia (1=dull sensation to pinprick), or none (0=sharp sensation to pinprick).; Sensory distribution assessed in the following areas: thenar eminence and thumb tip (median nerve), dorsum of hand (radial nerve), fifth digit fingertip (ulnar nerve), lateral aspect of forearm (musculocutaneous nerve) and medial aspect of forearm (medial antebrachial cutaneous nerve).; Successful blockade is defined by a sensory-motor score = 3.	40 minutes
Secondary	Feasibility of the wrist surgery	Usage (or not) of an additional anesthetic procedure to perform the surgery	2 hours
Secondary	Duration of postoperative analgesia	Time between the performance of regional anesthesia and the first dose of rescue analgesia with opioides.	72 hours
Secondary	Postoperative morphine consumption	Cumulated dose of oxynorm (mg)	48 hours
Secondary	Sleep quality	Incidence of sleep disorders	Day 2 After Surgery
Secondary	Complications during block performance	Incidence of vascular puncture, paresthesia, intraneural injection and intravascular passage	15 minutes
Secondary	Complications immediately after block	Onset of vertigo, nausea or vomiting	2 hours
Secondary	Postoperative complications	Questionnaire about potential sensory anomalies such as numbness, itching or tingling	Day 15 After Surgery