Clinical trial
WALANT Versus Axillary Brachial Plexus Block in Carpal Tunnel Release: a Non-inferiority Randomized Controlled Trial
Name
2023/02
Description
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).
Trial arms
Trial start
2024-05-13
Estimated PCD
2025-11-13
Trial end
2025-11-13
Status
Recruiting
Treatment
BAX
Injection of 30 mL of lidocaine (10 mg/ml) around the median, radial, ulnar and musculocutaneous nerves.
Arms:
BAX group
Tourniquet
Inflation pressure 75 to 100 mmHg above the patient's systolic blood pressure.
Arms:
BAX group
Lidocaine
Axillary block with Lidocaine (10 mg/ml).
Arms:
BAX group
WALANT
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.
Arms:
WALANT group
Lidocaine + Epinephrine
WALANT technique with lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine.
Arms:
WALANT group
Size
130
Primary endpoint
Regional anesthesia success
2 hours
Eligibility criteria
Inclusion Criteria:
* Patients undergoing endoscopic carpal tunnel release
* Consent for participation
* Affiliation to a social security system
Exclusion Criteria:
* 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}
Updated at
2024-05-28
1 organization
Organization
CMC Ambroise Paré