WALANT Procedure in Carpal Tunnel Release

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-02

Study Completion Date

2023-01-25

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Carpal Tunnel Median Nerve Neuralgia Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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WALANT procedure

Local anesthesia of the WALANT type

Group Type EXPERIMENTAL

Experimental: WALANT procedure

Intervention Type 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.

Axial ALR

Axillary loco-regional anesthesia

Group Type ACTIVE_COMPARATOR

Active Comparator: Axial ALR

Intervention Type 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.

Truncal ALR

Truncal loco-regional anesthesia

Group Type ACTIVE_COMPARATOR

Active Comparator: Truncal ALR

Intervention Type 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.

Interventions

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Experimental: WALANT 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.

Intervention Type PROCEDURE

Active Comparator: Axial ALR

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.

Intervention Type PROCEDURE

Active Comparator: Truncal ALR

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No