WALANT Procedure in Carpal Tunnel Release
NCT04924348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2023-03-10
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).
Conditions
- Carpal Tunnel
- Median Nerve Neuralgia
- Anesthesia, Local
Interventions
- PROCEDURE
-
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.
- 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.
- 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.
Sponsors & Collaborators
-
Elsan
lead OTHER
Principal Investigators
-
Flore-Anne LECOQ, MD · Institut de la Main Nantes Atlantique
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-02
- Primary Completion
- 2022-02-15
- Completion
- 2023-01-25
Countries
- France
Study Locations
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