WALANT Technique (Wide Awake Local Anesthesia No Tourniquet) for Carpal Tunnel Release.

WALANT Technique (Wide Awake Local Anesthesia No Tourniquet) in Association With Analgesic Troncular Blocks at the Wirst for Carpal Tunnel Release.

Sponsors

Lead Sponsor: CMC Ambroise Paré

Source CMC Ambroise Paré
Brief Summary

The carpal tunnel release (CTR) is now performed almost exclusively under regional anesthesia (RA) in France. RA requires the use of a pneumatic tourniquet to limit blood flow to the operated extremity and create a bloodless surgical field for a clear visualization of the anatomic structures by the surgeon.

Multiple approaches to block the brachial plexus can be considered. The most common technique is the axillary block (BAX) that provides complete anesthesia for the patient's arm and forearm. This technique offers anesthesia not only for the surgical area but also for the root of the arm where the pneumatic tourniquet is placed. However this technique have limits: the persistence of a motor block in the arm and the forearm that is not compatible with a quick hospital discharge (short term ambulatory hospitalization) and the need for assistance with dressing and eating after surgery. More distal anesthetic techniques are proposed such as the troncular blocks (TRONC) that avoid motor block of the arm and offer an earlier recovery and autonomy for the patient. However, they lead to a poor tolerance to the tourniquet due to its application on a non-anesthetized area.The pain related to the pressure of the tourniquet can occur within the first few minutes of its inflation, get worse over time and persist for several minutes after its deflation. Therefore, TRONC procedure is less often performed compared to the BAX for major surgeries but it remains appropriate for CTR.

The Wide Awake Local Anesthesia No Tourniquet (WALANT) technique is widely used in Canada and has been proposed for hand and wirst minor surgeries. WALANT uses a combination of a local anesthetic (LA) and epinephrine to induce anesthesia and hemostasis in the area of the surgical procedure in order to allow surgeries to be done without the use of tourniquet. Epinephrine is a vasoconstrictor agent that reduces blood flow at surgical site. This bloodless effect is visualized on the skin by a pale color. Thus, WALANT can provide a chemical tourniquet and eliminate the pain from a traditional arm tourniquet. However, this technique is performed with a short-acting LA and does not offer any postoperative analgesia.

The association of TRONC using long-acting LA with the WALANT technique could combine the comfort of a surgery without tourniquet to a long-acting analgesia and thus could provide a superior overall comfort.

The main objective of this prospective, multicentre, randomized, open-label, parallel-group controlled trial is to evaluate the interest of WALANT technique on patient comfort during CTR performed with TRONC, compared to the tourniquet.

Detailed Description

This is a multicenter, prospective, randomized, open-label study assessing the interest of the association of the WALANT local infiltration technique with analgesic troncular blocks (TRONC) at the wrist, for the endoscopic CTR.

This study compares two groups:

- CONTROL group (usual technique) : TRONC (using a long-acting LA : Ropivacaine) + Tourniquet

- WALANT group (experimental technique) : TRONC (using a long-acting LA : Ropivacaine) + WALANT ( using a short-term LA : Lidocaine + epinephrine)

RA procedures will be systematically performed under ultrasound guidance, 45 min befor surgery. Before each procedure, a skin disinfection will be carried out using an alcoholic iodine solution. The needle approach will be in-plane (IP) or out-of-plane (OOP). Efficiency will be assessed before transfer to the operating room.

- Troncular blocks (TRONC) Patients will be installed in supine position, the arm at 90° of abduction and in external rotation. The probe will be positioned to have an axial view of the nerves at the wrist. The initial identification of the median (nM) and ulnar (nU) nerves will be systematically done before each TRONC. The nM will be located on the anterior forearm. The nU will be visualized in contact with the ulnar artery in the forearm. The operator will inject 3 to 7 mL of Ropivacaine 3.75 mg/ml per nerve. An infiltration of 2 ml of Ropivacaine 3.75 mg/ml will be performed laterally above the flexion fold of the wrist in order to block the branches of the lateral cutaneous nerve of the forearm, the terminal sensory branch of the musculocutaneous nerve (nMC). A 22 Gauge x 50 mm needle will be used for TRONC.

- WALANT infiltration ("WALANT" group) An infiltration of the subcutaneous area in front of the transverse ligament will be performed between the thenar and hypothenar eminences, from the flexion fold of the wrist over a length of 5 cm. The path of the nM in the palm of the hand will be checked before each procedure. 3 to 7 ml of 1% lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine and 8.4% sodium bicarbonate (1 ml per 10 ml of lidocaine) will be injected. The addition of sodium bicarbonate will reduce the pain due to lidocaine injection. A 24 Gauge x 50 mm needle will be used for WALANT.

- Usage of pneumatic Tourniquet A pneumatic tourniquet will be placed at the root of the arm in all patients. A cuff with size and shape adapted to the patient will be used. The tourniquet will be inflated in all patients of "CONTROL" group, and if necessary, corresponding to the failure of the WALANT technique, in patients of "WALANT" group. The inflation pressure will be determined according to the patient's systolic blood pressure (SBP). It will be inflated 75 to 100 mmHg above SBP

Overall Status Not yet recruiting
Start Date September 15, 2020
Completion Date September 30, 2022
Primary Completion Date September 15, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Patient comfort during CTR 4 hours
Secondary Outcome
Measure Time Frame
Quality of the endoscopic surgical procedure 4 hours
Troncular block success 30 minutes
WALANT technique success 30 minutes
Hemostasis quality for the WALANT group 4 hours
Patient satisfaction 4 hours
Surgery duration 4 hours
Rate of complications 20 days
Enrollment 60
Condition
Intervention

Intervention Type: Procedure

Intervention Name: TRONC

Description: injection of 3 to 7 mL of Ropivacaine 3.75 mg/ml per nerve: (median and ulnar nerves) and infiltration of 2 ml of Ropivacaine 3.75 mg/ml laterally above the flexion fold of the wrist in order to block the branches of the lateral cutaneous nerve of the forearm, the terminal sensory branch of the musculocutaneous nerve.

Intervention Type: Procedure

Intervention Name: WALANT

Description: infiltration with 3 to 7 ml of 1% lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine and 8.4% sodium bicarbonate in the subcutaneous area in front of the transverse ligament, between the thenar and hypothenar eminences, from the flexion fold of the wrist over a length of 5 cm.

Arm Group Label: WALANT

Intervention Type: Procedure

Intervention Name: Tourniquet

Description: inflation pressure 75 to 100 mmHg above systolic blood pressure.

Arm Group Label: CONTROL

Eligibility

Criteria:

Inclusion Criteria:

- Patients undergoing endoscopic carpal tunnel release

- Consent for participation

- Affiliation to a social security system

Exclusion Criteria:

- Chronic pain syndrome or fibromyalgia

- Contraindication for locoregional anesthesia

- ASA 4

- Pregnant or breastfeeding women

- Patients under protection of the adults(guardianship, curators or safeguard of justice)

- Communication difficulties or neuropsychiatric disorder

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Sébastien Bloc, MD

Phone: 0146415079

Email: [email protected]

Location
Facility: Contact: Investigator:
Clinique Jouvenet | Paris, Ile-de-France, 75016, France Frédéric Le Saché, MD [email protected] Frédéric Le Saché, MD Principal Investigator
Clinique Rémusat | Paris, Ile-de-France, 75016, France Sébastien Bloc, MD [email protected] Sébastien Bloc, MD Principal Investigator
Location Countries

France

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: CONTROL

Type: Active Comparator

Description: Troncular blocks using a long-acting LA + Tourniquet

Label: WALANT

Type: Experimental

Description: Troncular blocks using a long-acting LA + WALANT technique using a short-term LA with epinephrine a vasoconstrictor agent

Acronym WALA
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov