WALANT Procedure in Carpal Tunnel Release

Elsan

Status: Completed

Conditions: Median Nerve Neuralgia; Anesthesia, Local; Carpal Tunnel

Treatments: Procedure: Active Comparator: Axial ALR; Procedure: Experimental: WALANT procedure; Procedure: Active Comparator: Truncal ALR

Study type: Interventional

Funder types: Other

Identifiers

NCT04924348

2020-A00446-33 (Other Identifier)

WALANT

Details and patient eligibility

About

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).

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 3 patient groups

WALANT procedure

Experimental group

Description:

Local anesthesia of the WALANT type

Treatment:

Procedure: Experimental: WALANT procedure

Axial ALR

Active Comparator group

Description:

Axillary loco-regional anesthesia

Treatment:

Procedure: Active Comparator: Axial ALR

Truncal ALR

Active Comparator group

Description:

Truncal loco-regional anesthesia

Treatment:

Procedure: Active Comparator: Truncal ALR