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

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ClinicalTrials.gov Identifier: NCT04046744
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
CMC Ambroise Paré

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.


Condition or disease Intervention/treatment Phase
Wrist Fracture Procedure: Axillary brachial plexus block with a long-acting local anesthetic Procedure: Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic Drug: Ropivacaine Drug: Lidocaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Axillary Block in Association With Analgesic Truncal Blocks of the Median and Radial Nerves at the Elbow for Wrist Surgery.
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : October 8, 2022
Estimated Study Completion Date : October 21, 2022

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%

Experimental: BAX-Asso 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: Ropivacaine
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%




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046744


Contacts
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Contact: Sébastien Bloc, MD (+33)662135682 agsb@mac.com

Locations
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France
Clinique Médipôle Garonne Not yet recruiting
Toulouse, Haute-Garonne, France, 31036
Contact: Alain Delbos, MD       alaindelbos@wanadoo.fr   
Principal Investigator: Alain Delbos, MD         
Sub-Investigator: Philippe Marty, MD         
Sub-Investigator: Clément Chassery, MD         
Sub-Investigator: Olivier Rontes, MD         
Clinique Lille Sud Not yet recruiting
Lesquin, Hauts-de-France, France, 59810
Contact: Damien Classeau, MD       damienclasseau@gmail.com   
Principal Investigator: Damien Classeau, MD         
Clinique Bizet Not yet recruiting
Paris, Ile-de -France, France, 75016
Contact: Mohammed Cheikh, MD         
Principal Investigator: Mohammed Cheikh, MD         
Hôpital Privé Paul D'Egine Recruiting
Champigny-sur-Marne, Ile-de-France, France, 94500
Contact: Christophe Heriche, MD       heriche@noos.fr   
Principal Investigator: Christophe Heriche, MD         
Clinique La Montagne Not yet recruiting
Courbevoie, Ile-de-France, France, 92400
Contact: Mario Paolo Bucciero, MD       mariobucciero@gmail.com   
Principal Investigator: Mario Paolo Bucciero, MD         
CMC Ambroise Paré Recruiting
Neuilly-sur-Seine, Ile-de-France, France, 92200
Contact: Sébastien Bloc, MD       agsb@mac.com   
Hôpital Privé Armand Brillard Recruiting
Nogent-sur-Marne, Ile-de-France, France, 94130
Contact: Sébastien Campion, MD         
Principal Investigator: Sébastien Campion, MD         
Clinique Jouvenet Recruiting
Paris, Ile-de-France, France, 75016
Contact: Frédéric Le Saché, MD       frederic.le-sache@aphp.fr   
Principal Investigator: Frédéric Le Saché, MD         
Sub-Investigator: Xavier Raingeval, MD         
Clinique Rémusat Recruiting
Paris, Ile-de-France, France, 75016
Contact: Sébastien BLOC, MD       agsb@mac.com   
Principal Investigator: Sébastien Bloc, MD         
Sub-Investigator: Frédéric Le Saché, MD         
Sponsors and Collaborators
CMC Ambroise Paré
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Responsible Party: CMC Ambroise Paré
ClinicalTrials.gov Identifier: NCT04046744    
Other Study ID Numbers: 2019/03
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CMC Ambroise Paré:
Regional anesthesia
Analgesia
Ultrasound
Additional relevant MeSH terms:
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Lidocaine
Analgesics
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action