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

Study Overview
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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.

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

Conditions
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Wrist Fracture

Intervention / Treatment
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* 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: Ropivacaine
* Drug: Lidocaine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BAX<br> | Procedure: Axillary brachial plexus block with a long-acting local anesthetic<br>* axillary block with 15-30 ml Ropivacaine 0,5%.<br>Drug: Ropivacaine<br>* axillary block with 15-30 ml Ropivacaine 0,5%<br>|
| Experimental: BAX-Asso<br> | Procedure: Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic<br>* axillary block with 15-30 ml Lidocaine 1,5% + radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%.<br>Drug: Ropivacaine<br>* radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%<br>Drug: Lidocaine<br>* axillary block with 15-30 ml Lidocaine 1,5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of motor block at the elbow | Time between the performance of regional anesthesia and the elbow flexion recovery | 24 hours | 
| 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 | 
| Feasibility of the wrist surgery | Usage (or not) of an additional anesthetic procedure to perform the surgery | 2 hours | 
| Duration of postoperative analgesia | Time between the performance of regional anesthesia and the first dose of rescue analgesia with opioides. | 72 hours | 
| Postoperative morphine consumption | Cumulated dose of oxynorm (mg) | 48 hours | 
| Sleep quality | Incidence of sleep disorders | Day 2 After Surgery | 
| Complications during block performance | Incidence of vascular puncture, paresthesia, intraneural injection and intravascular passage | 15 minutes | 
| Complications immediately after block | Onset of vertigo, nausea or vomiting | 2 hours | 
| Postoperative complications | Questionnaire about potential sensory anomalies such as numbness, itching or tingling | Day 15 After Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional anesthesia, Analgesia, Ultrasound