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

C

CMC Ambroise Paré

Status

Completed

Conditions

Wrist Fracture

Treatments

Procedure: Axillary brachial plexus block with a long-acting local anesthetic
Drug: Lidocaine
Drug: Ropivacaine
Procedure: Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic

Study type

Interventional

Funder types

Other

Identifiers

NCT04046744
2019/03

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

BAX
Active Comparator group
Treatment:
Drug: Ropivacaine
Procedure: Axillary brachial plexus block with a long-acting local anesthetic
Drug: Ropivacaine
BAX-Asso
Experimental group
Treatment:
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
Drug: Ropivacaine

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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