WALANT Versus Axillary Brachial Plexus Block in Carpal Tunnel Release

NCT06040840 | Completed

• 1 other identifier: 2023/02
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Carpal tunnel syndrome (CTS) is a common medical condition that remains one of the most frequently reported forms of median nerve compression. Surgical procedure is a treatment option for CTS. For this surgery of the upper extremity, regional anesthesia (RA) is the strategy that should be systematically preferred because it is associated with shorter postanesthetic care and less pain compared to general anesthesia. Multiple approaches to block the brachial plexus are available for the surgery of the upper extremity below the elbow, but the axillary block (BAX) remains the most common approach as it is associated with low side effects. One of the most significant recent advances in the surgery of the upper extremity has been the emergence of Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique. WALANT is an infiltration technique of a local anesthetic (LA) (lidocaine) and a hemostatic agent (epinephrine) directly into the operative site to induce anesthesia and hemostasis in the area of the surgical procedure to provide conditions suitable for hand surgery without sedation and tourniquet. Given its effectiveness and low side effects, WALANT could be a technique of choice in ambulatory surgery. The main objective of this non-inferiority, prospective, randomized, open-label, parallel-group controlled trial is to assess the efficacy of WALANT technique compared to BAX in carpal tunnel release (CTR).

Conditions

Carpal Tunnel Syndrome

Keywords

WALANT; Axillary block; Regional anesthesia; Tourniquet; Carpal Tunnel Release; Postoperative analgesia; Perioperative patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Regional anesthesia success

  Need (or not) for additional anesthetic procedure during surgery: analgesics, sedation, general anesthesia, local anesthetics

  2 hours

Secondary Outcomes (7)

• Surgery duration

  2 hours

• Length of hospital stay

  24 hours

• Discharge criteria assessed by PADSS

  24 hours

• Patient satisfaction assessed by EVAN-LR self-reported questionnaire

  24 hours

• Postoperative pain at the surgical site assessed by VRS

  24 hours

Study Arms (2)

BAX group

ACTIVE COMPARATOR

Axillary brachial plexus block + Tourniquet

Procedure: BAX; Procedure: Tourniquet; Drug: Lidocaine

WALANT group

EXPERIMENTAL

Wide Awake Local Anesthesia No Tourniquet

Procedure: WALANT; Drug: Lidocaine + Epinephrine

Interventions

BAX PROCEDURE

Injection of 30 mL of lidocaine (10 mg/ml) around the median, radial, ulnar and musculocutaneous nerves.

BAX group

Tourniquet PROCEDURE

Inflation pressure 75 to 100 mmHg above the patient's systolic blood pressure.

BAX group

Lidocaine DRUG

Axillary block with Lidocaine (10 mg/ml).

BAX group

WALANT PROCEDURE

Preparation of a mixture of 20 ml of lidocaine (10 mg/ml) with epinephrine (0.005 mg/ml) + 3 ml Na bicarbonate (84 mg/ml) + 17 ml sterile normal saline. The ultrasound probe will be placed to obtain a transverse image of the median nerve at the wrist. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of 5 ml of the solution posterior and then anterior to the median nerve under the annular carpal ligament. Then the ultrasound probe will be placed to obtain a longitudinal image of the median nerve at the wrist. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of 15 ml of the solution anterior to the median nerve towards the carpal tunnel. At last, a local infiltration with 5 ml of the solution will be performed around the surgical incision.

WALANT group

Lidocaine + Epinephrine DRUG

WALANT technique with lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine.

WALANT group

Eligibility Criteria

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

You may qualify if:

• Patients undergoing endoscopic carpal tunnel release
• Consent for participation
• Affiliation to a social security system

You may not qualify if:

• Contraindication for regional anesthesia (truncal neuropathy, infection at the puncture site, coagulation disorder, …)
• Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, propofol, lidocaine, epinephrine)
• Chronic pain syndrome
• Preoperative Anxiety
• Pregnant or breastfeeding women
• Patients under protection of the adults (guardianship, curators or safeguard of justice)

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

Clinique Médipôle Garonne

Toulouse, Haute-Garonne, 31036, France

Location

Related Publications (1)

• Virtos M, Chassery C, Marty P, Basset B, Casalprim J, Vuillaume C, De Lussy A, Atthar V, Naudin C, Joshi G, Rontes O. Wide awake local anesthesia no tourniquet (WALANT) versus ultrasound-guided axillary block in carpal tunnel release: a non-inferiority randomized controlled trial. Reg Anesth Pain Med. 2025 Nov 13:rapm-2025-107152. doi: 10.1136/rapm-2025-107152. Online ahead of print.

  PMID: 41233154 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Tourniquets; Lidocaine; Epinephrine

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 18, 2023
• Study Start: May 13, 2024
• Primary Completion: January 27, 2025
• Study Completion: January 28, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

FR (1)