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Completed

NCT Number: NCT04046744

Axillary Block in Association With Analgesic Truncal Blocks 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.

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Key information

Conditions

Wrist Fracture Agnosia Arm Injuries Fractures, Bone Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique du Pré, Le Mans, Pays de la Loire Region, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axillary brachial plexus block with a long-acting local anesthetic

Procedure

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

Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic

Procedure

axillary block with 15-30 ml Lidocaine 1,5% + radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%.

Ropivacaine

Drug

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

Lidocaine

Drug

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

Primary outcomes

  1. Level of pain when the patient recovers the flexion of the forearm on the arm

    Time frame: 24 hours

    Pain VRS ranging from 0 to 10 (0=no pain, 10=worst possible pain)

Secondary outcomes

  1. Duration of motor block at the elbow

    Time frame: 24 hours

    Time between the performance of regional anesthesia and the elbow flexion recovery

  2. Axillary block success

    Time frame: 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.

  3. Feasibility of the wrist surgery

    Time frame: 2 hours

    Usage (or not) of an additional anesthetic procedure to perform the surgery

  4. Duration of postoperative analgesia

    Time frame: 72 hours

    Time between the performance of regional anesthesia and the first dose of rescue analgesia with opioides.

  5. Postoperative morphine consumption

    Time frame: 48 hours

    Cumulated dose of oxynorm (mg)

  6. Sleep quality

    Time frame: Day 2 After Surgery

    Incidence of sleep disorders

  7. Complications during block performance

    Time frame: 15 minutes

    Incidence of vascular puncture, paresthesia, intraneural injection and intravascular passage

  8. Complications immediately after block

    Time frame: 2 hours

    Onset of vertigo, nausea or vomiting

  9. Postoperative complications

    Time frame: Day 15 After Surgery

    Questionnaire about potential sensory anomalies such as numbness, itching or tingling

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Official study title

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

Acronym: BAXASSO

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2019
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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