Clinical trial NCT04046744: Axillary Block in Association With Analgesic Truncal Blocks at the Elbow for Wrist Surgery.
Official title: Axillary Block in Association With Analgesic Truncal Blocks of the Median and Radial Nerves at the Elbow for Wrist Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrist Fracture
Keywords: Regional anesthesia
Analgesia
Ultrasound
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of pain when the patient recovers the flexion of the forearm on the arm
timeFrame: 24 hours
Secondary outcomes:
measure: Duration of motor block at the elbow
timeFrame: 24 hours
measure: Axillary block success
timeFrame: 40 minutes
measure: Feasibility of the wrist surgery
timeFrame: 2 hours
measure: Duration of postoperative analgesia
timeFrame: 72 hours
measure: Postoperative morphine consumption
timeFrame: 48 hours
measure: Sleep quality
timeFrame: Day 2 After Surgery
measure: Complications during block performance
timeFrame: 15 minutes
measure: Complications immediately after block
timeFrame: 2 hours
measure: Postoperative complications
timeFrame: Day 15 After Surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Bizet
state: Ile-de -France
city: Champigny-sur-Marne
country: France
facility: Hôpital Privé Paul D'Egine
state: Ile-de-France
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Paré
state: Ile-de-France
city: Nogent-sur-Marne
country: France
facility: Hôpital Privé Armand Brillard
state: Ile-de-France
city: Paris
country: France
facility: Clinique Jouvenet
state: Ile-de-France
city: Paris
country: France
facility: Clinique Rémusat
state: Ile-de-France
city: Le Mans
country: France
facility: Clinique du Pré
state: Pays De La Loire
Study officials:
References: