WALANT Procedure in Carpal Tunnel Release

NCT04924348 | Completed

• 2 other identifiers: WALANT2020-A00446-33
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The possible benefits expected from the use of the WALANT procedure are a decrease in intraoperative pain at the surgical site, a decrease in hospitalization time, and a decrease in the time required to lift the anesthesia postoperatively. The risks identified are those inherent to each type of anesthesia (WALANT or traditional ALR), as encountered in current practice, and are therefore not specific to the study: risks related to the local anesthetic agent or risks related to the puncture procedure. The main objective is to determine whether the patient's intraoperative pain at the surgical site is less after a WALANT procedure compared to a traditional ALR procedure (axillary or trunk).

Conditions

Carpal Tunnel; Median Nerve Neuralgia; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Evaluation of the patient's pain intraoperatively at the surgical site.

  Evaluation of the patient's pain, at the level of the operative site by a visual analog scale from 0 to 10 where 0 equals to "No Pain" and 10 equals to "Extremely severe pain".

  Within 24 hours after intervention

Secondary Outcomes (21)

• Visual Analog Scale for intraoperative pain at the surgical site

  intraoperative

• Satisfaction scores

  Within 24 hours after intervention

• Satisfaction scores

  One day after intervention

• Assessment of the patient's overall pain after surgery

  One day after intervention

• Assessment of the patient's overall pain after surgery

  One month after intervention

Study Arms (3)

WALANT procedure

EXPERIMENTAL

Local anesthesia of the WALANT type

Procedure: Experimental: WALANT procedure

Axial ALR

ACTIVE COMPARATOR

Axillary loco-regional anesthesia

Procedure: Active Comparator: Axial ALR

Truncal ALR

ACTIVE COMPARATOR

Truncal loco-regional anesthesia

Procedure: Active Comparator: Truncal ALR

Interventions

Experimental: WALANT procedure PROCEDURE

The WALANT technique, performed under ultrasound, includes two punctures. * The first is a puncture through a medial approach above the wrist and includes two injections. A first subcutaneous injection reproducing a bar above the wrist flexion line, and a second injection above the median nerve. The volumes injected vary from 8 to 10 milliliters (ml). * The second puncture is performed at the base of the palmar surface of the hand and consists of a 10 ml subcutaneous injection of the local anesthetic in order to take advantage of the vasoconstrictive effects of adrenaline, thus allowing the surgical procedure to be performed without a pneumatic tourniquet.

WALANT procedure

Active Comparator: Axial ALR PROCEDURE

The anesthetic protocol in the axillary block consists of performing a puncture, using a needle (50 mm 22G with a short bevel), under the armpit at the level of the axillary hollow after skin disinfection. This puncture, performed under ultrasound, allows the injection of the local anesthetic around the median, radial, ulnar and musculocutaneous nerves. The volume injected per nerve can vary from 5 to 8 ml depending on the visual appreciation during the injection.

Axial ALR

Active Comparator: Truncal ALR PROCEDURE

The anesthetic protocol in truncal block consists in injecting the local anesthetic around the median and ulnar nerves by a puncture performed at the elbow or forearm (depending on the practitioner's experience). The volumes injected remain the same and the puncture is also performed under ultrasound guidance. Additional local anesthesia is administered by injecting an additional 5 ml above the wrist flexion line to block the sensory territory of the musculocutaneous nerve.

Truncal ALR

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient over 18 years of age
• Membership in a mandatory health insurance plan
• Patient treated for a first median nerve liberation surgery at the carpal tunnel
• Patient having been informed of the study and having given informed consent
• French-speaking patient

You may not qualify if:

• Surgical revision
• Contraindication(s) to loco-regional anesthesia :
• Coagulation disorder or ongoing anticoagulant therapy
• Existing peripheral neuropathy
• Amide-type AL allergy
• Pregnant or breastfeeding women
• Inability to undergo the medical follow-up of the study for geographical, social or psychological reasons
• Patients under legal protection
• Patients under the influence of drugs that may interfere with the anesthetic techniques under study (cocaine, cannabis, etc. as judged by the investigator)

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Institut de la main Nantes Atlantique

Saint-Herblain, 44800, France

Location

Related Publications (7)

• Lalonde DH. Conceptual origins, current practice, and views of wide awake hand surgery. J Hand Surg Eur Vol. 2017 Nov;42(9):886-895. doi: 10.1177/1753193417728427. Epub 2017 Sep 8.

  PMID: 28886668 BACKGROUND

• Tulipan JE, Kim N, Abboudi J, Jones C, Liss F, Kirkpatrick W, Rivlin M, Wang ML, Matzon J, Ilyas AM. Open Carpal Tunnel Release Outcomes: Performed Wide Awake versus with Sedation. J Hand Microsurg. 2017 Aug;9(2):74-79. doi: 10.1055/s-0037-1603200. Epub 2017 May 22.

  PMID: 28867906 BACKGROUND

• Lalonde D, Martin A. Tumescent local anesthesia for hand surgery: improved results, cost effectiveness, and wide-awake patient satisfaction. Arch Plast Surg. 2014 Jul;41(4):312-6. doi: 10.5999/aps.2014.41.4.312. Epub 2014 Jul 15.

  PMID: 25075350 BACKGROUND

• Steiner MM, Calandruccio JH. Use of Wide-awake Local Anesthesia No Tourniquet in Hand and Wrist Surgery. Orthop Clin North Am. 2018 Jan;49(1):63-68. doi: 10.1016/j.ocl.2017.08.008.

  PMID: 29145985 BACKGROUND

• Wright J, MacNeill AL, Mayich DJ. A prospective comparison of wide-awake local anesthesia and general anesthesia for forefoot surgery. Foot Ankle Surg. 2019 Apr;25(2):211-214. doi: 10.1016/j.fas.2017.10.015. Epub 2017 Nov 6.

  PMID: 29409279 BACKGROUND

• Fayad F, Lefevre-Colau MM, Gautheron V, Mace Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Revel M, Poiraudeau S. Reliability, validity and responsiveness of the French version of the questionnaire Quick Disability of the Arm, Shoulder and Hand in shoulder disorders. Man Ther. 2009 Apr;14(2):206-12. doi: 10.1016/j.math.2008.01.013. Epub 2008 Apr 23.

  PMID: 18436467 BACKGROUND

• Estebe JP, Gentili ME, Langlois G, Mouilleron P, Bernard F, Ecoffey C. Lidocaine priming reduces tourniquet pain during intravenous regional anesthesia: A preliminary study. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):120-3. doi: 10.1053/rapm.2003.50123.

  PMID: 12677622 BACKGROUND

Related Links

• Points to consider on multiplicity issues in clinical trials, EMEA, 2002

MeSH Terms

Conditions

Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Flore-Anne LECOQ, MD

  Institut de la Main Nantes Atlantique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, prospective, therapeutic, comparative, randomized controlled open-label, non-inferiority, single-center, national study.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 14, 2021
• Study Start: December 2, 2020
• Primary Completion: February 15, 2022
• Study Completion: January 25, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)