Clinical trial NCT04924348: WALANT Procedure in Carpal Tunnel Release
Official title: WALANT (Wide Awake Local Anaesthesia With No Tourniquet) Procedure in Carpal Tunnel Release: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel
Median Nerve Neuralgia
Anesthesia, Local
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, prospective, therapeutic, comparative, randomized controlled open-label, non-inferiority, single-center, national study.
Primary purpose: PREVENTION

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).

Detailed description: Median nerve neurolysis at the carpal tunnel is one of the most performed procedures in the world. The use of loco-regional anesthesia (LRA) is common practice for this surgery, especially since the use of ultrasound guidance, which allows visualization of the nerves and control of the injection of anesthetic products, makes it a safe technique. The nerve blocks most commonly used in hand surgery are axillary blocks and truncal blocks. The choice between these two techniques, which are equivalent in terms of effectiveness and duration of anesthesia, depends in practice on the habits of each practitioner. As the use of a pneumatic tourniquet during the operation is systematic, the axillary block, by anaesthetizing the whole arm, avoids the discomfort described by some patients when using a tourniquet. For others, the discomfort is related to the sensation of a "dead arm" with a duration of anesthesia of several hours, which the truncular block makes it possible to avoid.

Recently, an alternative to traditional LRA by local anesthesia without tourniquet and without sedation (WALANT procedure: Wide Awake Local Anesthesia with No Tourniquet) has been described. Several studies show the efficacy and safety of this procedure, which is already used in current practice.

However, to date, there is no comparative study evaluating the effectiveness of the WALANT procedure compared to traditional hand surgery techniques for carpal tunnel, neither published nor in progress. This is the purpose of this study.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Surgical revision
* Contraindication(s) to loco-regional anesthesia :

  1. Coagulation disorder or ongoing anticoagulant therapy
  2. Existing peripheral neuropathy
  3. 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)
* Inclusion of the subject in another research protocol during this study

Primary outcomes:
measure: Evaluation of the patient's pain intraoperatively at the surgical site.
timeFrame: Within 24 hours after intervention
Secondary outcomes:
measure: Visual Analog Scale for intraoperative pain at the surgical site
timeFrame: intraoperative
measure: Satisfaction scores
timeFrame: Within 24 hours after intervention
measure: Satisfaction scores
timeFrame: One day after intervention
measure: Assessment of the patient's overall pain after surgery
timeFrame: One day after intervention
measure: Assessment of the patient's overall pain after surgery
timeFrame: One month after intervention
measure: Assessment of the patient's overall pain after surgery
timeFrame: Three months after intervention
measure: Assessment of the patient's overall pain after surgery
timeFrame: Six months after intervention
measure: Evaluation of the return to work after surgery
timeFrame: Within 24 hours after intervention
measure: Evaluation of the return to work after surgery
timeFrame: One month after intervention
measure: Evaluation of the return to work after surgery
timeFrame: Three months after intervention
measure: Evaluation of the return to work after surgery
timeFrame: Six months after intervention
measure: Evaluation of the quality of life
timeFrame: Baseline (Before the anesthesia)
measure: Evaluation of the quality of life
timeFrame: One month after intervention
measure: Evaluation of the quality of life
timeFrame: Three months after intervention
measure: Evaluation of the quality of life
timeFrame: Six months after intervention
measure: Evaluation of the use of analgesics in the postoperative situation
timeFrame: One day after intervention
measure: Evaluation of the failure rates of different anesthesia procedures.
timeFrame: Within 24 hours after intervention
measure: Evaluation of the operative time.
timeFrame: During surgery
measure: Evaluation of the hospitalization length.
timeFrame: Within 24 hours after intervention
measure: Evaluation of the time to release of anesthesia.
timeFrame: Within 24 hours after intervention
measure: Evaluation of the safety of different types of anesthesia.
timeFrame: One month after intervention
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: Institut de la main Nantes Atlantique
Study officials:
affiliation: Institut de la Main Nantes Atlantique
name: Flore-Anne LECOQ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.