Axillary Block in Association With Analgesic Truncal Blocks at the Elbow for Wrist Surgery.
- Conditions
- Wrist Fracture
- Interventions
- Procedure: Axillary brachial plexus block with a long-acting local anestheticProcedure: Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic
- Registration Number
- NCT04046744
- Lead Sponsor
- CMC Ambroise Paré
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Patients undergoing wrist fracture surgery under regional anesthesia
- Consent for participation
- Affiliation to the French social security system
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BAX Axillary brachial plexus block with a long-acting local anesthetic - BAX-Asso Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic - BAX-Asso Ropivacaine - BAX-Asso Lidocaine - BAX Ropivacaine -
- Primary Outcome Measures
Name Time Method Level of pain when the patient recovers the flexion of the forearm on the arm 24 hours Pain VRS ranging from 0 to 10 (0=no pain, 10=worst possible pain)
- Secondary Outcome Measures
Name Time Method Duration of motor block at the elbow 24 hours Time between the performance of regional anesthesia and the elbow flexion recovery
Feasibility of the wrist surgery 2 hours Usage (or not) of an additional anesthetic procedure to perform the surgery
Postoperative morphine consumption 48 hours Cumulated dose of oxynorm (mg)
Axillary block success 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.Duration of postoperative analgesia 72 hours Time between the performance of regional anesthesia and the first dose of rescue analgesia with opioides.
Complications during block performance 15 minutes Incidence of vascular puncture, paresthesia, intraneural injection and intravascular passage
Complications immediately after block 2 hours Onset of vertigo, nausea or vomiting
Postoperative complications Day 15 After Surgery Questionnaire about potential sensory anomalies such as numbness, itching or tingling
Sleep quality Day 2 After Surgery Incidence of sleep disorders
Trial Locations
- Locations (7)
Clinique du Pré
🇫🇷Le Mans, Pays De La Loire, France
Clinique Bizet
🇫🇷Paris, Ile-de -France, France
CMC Ambroise Paré
🇫🇷Neuilly-sur-Seine, Ile-de-France, France
Hôpital Privé Paul D'Egine
🇫🇷Champigny-sur-Marne, Ile-de-France, France
Hôpital Privé Armand Brillard
🇫🇷Nogent-sur-Marne, Ile-de-France, France
Clinique Jouvenet
🇫🇷Paris, Ile-de-France, France
Clinique Rémusat
🇫🇷Paris, Ile-de-France, France