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

Sponsor

CMC Ambroise Paré (Other)

Overall Status

Recruiting

CT.gov ID

NCT04046744

Collaborator

(none)

150

Enrollment

Locations

Arms

36.5

Anticipated Duration (Months)

16.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

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: Ropivacaine Drug: Lidocaine	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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 :

Oct 7, 2019

Anticipated Primary Completion Date :

Oct 8, 2022

Anticipated Study Completion Date :

Oct 21, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: BAX

Procedure: Axillary brachial plexus block with a long-acting local anesthetic

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

Drug: Ropivacaine

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

Experimental: BAX-Asso

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%.

Drug: Ropivacaine

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

Drug: Lidocaine

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

Outcome Measures

Primary Outcome Measures

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

Duration of motor block at the elbow [24 hours]
Time between the performance of regional anesthesia and the elbow flexion recovery
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.
Feasibility of the wrist surgery [2 hours]
Usage (or not) of an additional anesthetic procedure to perform the surgery
Duration of postoperative analgesia [72 hours]
Time between the performance of regional anesthesia and the first dose of rescue analgesia with opioides.
Postoperative morphine consumption [48 hours]
Cumulated dose of oxynorm (mg)
Sleep quality [Day 2 After Surgery]
Incidence of sleep disorders
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Médipôle Garonne	Toulouse	Haute-Garonne	France	31036
2	Clinique Lille Sud	Lesquin	Hauts-de-France	France	59810
3	Clinique Bizet	Paris	Ile-de -France	France	75016
4	Hôpital Privé Paul D'Egine	Champigny-sur-Marne	Ile-de-France	France	94500
5	Clinique La Montagne	Courbevoie	Ile-de-France	France	92400
6	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France	France	92200
7	Hôpital Privé Armand Brillard	Nogent-sur-Marne	Ile-de-France	France	94130
8	Clinique Jouvenet	Paris	Ile-de-France	France	75016
9	Clinique Rémusat	Paris	Ile-de-France	France	75016