Axillary Block in Association With Analgesic Truncal Blocks at the Elbow for Wrist Surgery. (BAXASSO)
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|ClinicalTrials.gov Identifier: NCT04046744|
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : September 1, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Wrist Fracture||Procedure: Axillary brachial plexus block with a long-acting local anesthetic Procedure: Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic Drug: Ropivacaine Drug: Lidocaine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Axillary Block in Association With Analgesic Truncal Blocks of the Median and Radial Nerves at the Elbow for Wrist Surgery.|
|Actual Study Start Date :||October 7, 2019|
|Estimated Primary Completion Date :||October 8, 2022|
|Estimated Study Completion Date :||October 21, 2022|
|Active Comparator: BAX||
Procedure: Axillary brachial plexus block with a long-acting local anesthetic
axillary block with 15-30 ml Ropivacaine 0,5%.
axillary block with 15-30 ml Ropivacaine 0,5%
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%.
radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%
axillary block with 15-30 ml Lidocaine 1,5%
- Level of pain when the patient recovers the flexion of the forearm on the arm [ Time Frame: 24 hours ]Pain VRS ranging from 0 to 10 (0=no pain, 10=worst possible pain)
- Duration of motor block at the elbow [ Time Frame: 24 hours ]Time between the performance of regional anesthesia and the elbow flexion recovery
- Axillary block success [ Time Frame: 40 minutes ]
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.
- Feasibility of the wrist surgery [ Time Frame: 2 hours ]Usage (or not) of an additional anesthetic procedure to perform the surgery
- Duration of postoperative analgesia [ Time Frame: 72 hours ]Time between the performance of regional anesthesia and the first dose of rescue analgesia with opioides.
- Postoperative morphine consumption [ Time Frame: 48 hours ]Cumulated dose of oxynorm (mg)
- Sleep quality [ Time Frame: Day 2 After Surgery ]Incidence of sleep disorders
- Complications during block performance [ Time Frame: 15 minutes ]Incidence of vascular puncture, paresthesia, intraneural injection and intravascular passage
- Complications immediately after block [ Time Frame: 2 hours ]Onset of vertigo, nausea or vomiting
- Postoperative complications [ Time Frame: Day 15 After Surgery ]Questionnaire about potential sensory anomalies such as numbness, itching or tingling
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046744
|Contact: Sébastien Bloc, MD||(+33)email@example.com|
|Clinique Médipôle Garonne||Not yet recruiting|
|Toulouse, Haute-Garonne, France, 31036|
|Contact: Alain Delbos, MD firstname.lastname@example.org|
|Principal Investigator: Alain Delbos, MD|
|Sub-Investigator: Philippe Marty, MD|
|Sub-Investigator: Clément Chassery, MD|
|Sub-Investigator: Olivier Rontes, MD|
|Clinique Lille Sud||Not yet recruiting|
|Lesquin, Hauts-de-France, France, 59810|
|Contact: Damien Classeau, MD email@example.com|
|Principal Investigator: Damien Classeau, MD|
|Clinique Bizet||Not yet recruiting|
|Paris, Ile-de -France, France, 75016|
|Contact: Mohammed Cheikh, MD|
|Principal Investigator: Mohammed Cheikh, MD|
|Hôpital Privé Paul D'Egine||Recruiting|
|Champigny-sur-Marne, Ile-de-France, France, 94500|
|Contact: Christophe Heriche, MD firstname.lastname@example.org|
|Principal Investigator: Christophe Heriche, MD|
|Clinique La Montagne||Not yet recruiting|
|Courbevoie, Ile-de-France, France, 92400|
|Contact: Mario Paolo Bucciero, MD email@example.com|
|Principal Investigator: Mario Paolo Bucciero, MD|
|CMC Ambroise Paré||Recruiting|
|Neuilly-sur-Seine, Ile-de-France, France, 92200|
|Contact: Sébastien Bloc, MD firstname.lastname@example.org|
|Hôpital Privé Armand Brillard||Recruiting|
|Nogent-sur-Marne, Ile-de-France, France, 94130|
|Contact: Sébastien Campion, MD|
|Principal Investigator: Sébastien Campion, MD|
|Paris, Ile-de-France, France, 75016|
|Contact: Frédéric Le Saché, MD email@example.com|
|Principal Investigator: Frédéric Le Saché, MD|
|Sub-Investigator: Xavier Raingeval, MD|
|Paris, Ile-de-France, France, 75016|
|Contact: Sébastien BLOC, MD firstname.lastname@example.org|
|Principal Investigator: Sébastien Bloc, MD|
|Sub-Investigator: Frédéric Le Saché, MD|