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

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

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.

Study Overview

• Status: Completed
• Conditions: Wrist Fracture
• Intervention / Treatment: Procedure: Axillary brachial plexus block with a long-acting local anesthetic; Drug: Ropivacaine; Drug: Ropivacaine; Procedure: Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic; Drug: Lidocaine

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile-de -France
    • Paris, Ile-de -France, France, 75016
      • Clinique Bizet
  • Ile-de-France
    • Champigny-sur-Marne, Ile-de-France, France, 94500
      • Hôpital Privé Paul d'Egine
    • Neuilly-sur-Seine, Ile-de-France, France, 92200
      • CMC Ambroise Paré
    • Nogent-sur-Marne, Ile-de-France, France, 94130
      • Hôpital Privé Armand Brillard
    • Paris, Ile-de-France, France, 75016
      • Clinique Jouvenet
    • Paris, Ile-de-France, France, 75016
      • Clinique Rémusat
  • Pays De La Loire
    • Le Mans, Pays De La Loire, France, 72018
      • Clinique Du Pre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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%; Drug: Ropivacaine; radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%
Experimental: BAX-Asso	Drug: Ropivacaine; axillary block with 15-30 ml Ropivacaine 0,5%; Drug: Ropivacaine; radial and medial nerve block at the elbow with 3-7 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%.; Drug: Lidocaine; axillary block with 15-30 ml Lidocaine 1,5%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; Analgesia; Regional anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Lidocaine; Anesthetics, Local; Ropivacaine; Analgesics
• Other Study ID Numbers: 2019/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No