WALANT Procedure in Carpal Tunnel Release

Not Applicable

Completed

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

• Registration Number: NCT04924348
• Lead Sponsor: Elsan

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.

Study Timeline

• Study Start: 2020-12-02
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-14
• Primary Completion: 2022-02-15
• Study Completion: 2023-01-25
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of the patient's pain intraoperatively at the surgical site.	Within 24 hours after intervention	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".

Secondary Outcome Measures

Name	Time	Method
Satisfaction scores	One day after intervention	Satisfaction scores according to the forms provided in the appendices of the patient
Visual Analog Scale for intraoperative pain at the surgical site	intraoperative	The assessment of pain at the surgical site will be evaluated using a 10-point visual analog scale score from 0 to 10 where 0 equals to "No Pain" and 10 equals to "Extremely severe pain"
Evaluation of the hospitalization length.	Within 24 hours after intervention	Hospitalization length defined as the time from the patient's admission to the end of the hospitalization (in hours)
Evaluation of the return to work after surgery	Six months after intervention	Evaluation thanks to the Quick-DASH Questionnaire from 0 to 100 where 0 equals to "No disability" and 100 equals to "Most severe disability and reduced function"
Evaluation of the safety of different types of anesthesia.	One month after intervention	Collection of postoperative adverse events.
Assessment of the patient's overall pain after surgery	Six months after intervention	Assessment of the patient's overall pain after surgery using a numerical scale (EN) from 0 to 10 where 0 equals to "No Pain" and 10 equals to "Extremely severe pain"
Evaluation of the quality of life	Six months after intervention	Evaluation thanks to the SF-36 from 0 to 100 where 0 equals to "Poor Health" and 100 equals to "Good Health"
Evaluation of the use of analgesics in the postoperative situation	One day after intervention	The use of analgesics will be collected until D+1 by defining the following levels of analgesic intake: * Level I: use of a paracetamol-type analgesic, up to 4 g/day; * Level II: use of another type of analgesic (Tramadol or Lamaline®)
Evaluation of the operative time.	During surgery	Operating time defined as the time from skin incision to skin closure (in minutes)
Evaluation of the failure rates of different anesthesia procedures.	Within 24 hours after intervention	The following were considered procedural failures: need for intravenous sedation for all 3 groups, need to inflate the tourniquet (applied as a preventive measure) for the WALANT group only.
Evaluation of the time to release of anesthesia.	Within 24 hours after intervention	Time to release of anesthesia defined as the time from the placement of anesthesia to the release of motor (ability to clench/unclench the hand) and sensory (disappearance of tingling) anesthesia

Trial Locations

Locations (1)

Institut de la main Nantes Atlantique; 🇫🇷 Saint-Herblain, France