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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04046744
Acronym
BAXASSO
Enrollment
150
Registered
2019-08-06
Start date
2019-10-07
Completion date
2022-09-15
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wrist Fracture

Keywords

Regional anesthesia, Analgesia, Ultrasound

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.

Interventions

PROCEDUREAxillary brachial plexus block with a long-acting local anesthetic

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

PROCEDUREAxillary 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%.

DRUGRopivacaine

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

DRUGLidocaine

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

Sponsors

CMC Ambroise Paré
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Level of pain when the patient recovers the flexion of the forearm on the arm24 hoursPain VRS ranging from 0 to 10 (0=no pain, 10=worst possible pain)

Secondary

MeasureTime frameDescription
Duration of motor block at the elbow24 hoursTime between the performance of regional anesthesia and the elbow flexion recovery
Axillary block success40 minutesAssess 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 surgery2 hoursUsage (or not) of an additional anesthetic procedure to perform the surgery
Duration of postoperative analgesia72 hoursTime between the performance of regional anesthesia and the first dose of rescue analgesia with opioides.
Postoperative morphine consumption48 hoursCumulated dose of oxynorm (mg)
Sleep qualityDay 2 After SurgeryIncidence of sleep disorders
Complications during block performance15 minutesIncidence of vascular puncture, paresthesia, intraneural injection and intravascular passage
Complications immediately after block2 hoursOnset of vertigo, nausea or vomiting
Postoperative complicationsDay 15 After SurgeryQuestionnaire about potential sensory anomalies such as numbness, itching or tingling

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026