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

Sponsor

CMC Ambroise Paré (Other)

Overall Status

Completed

CT.gov ID

NCT04494100

Collaborator

(none)

Enrollment

Locations

Arms

9.8

Actual Duration (Months)

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Release	Procedure: TRONC Procedure: WALANT Procedure: Tourniquet Drug: Ropivacaine Drug: Lidocaine + Epinephrine	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 11, 2020

Actual Primary Completion Date :

Jun 25, 2021

Actual Study Completion Date :

Jul 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CONTROL Troncular blocks using a long-acting LA + Tourniquet	Procedure: TRONC 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. Procedure: Tourniquet inflation pressure 75 to 100 mmHg above systolic blood pressure. Drug: Ropivacaine troncular blocks with Ropivacaine 3.75 mg/ml
Experimental: WALANT Troncular blocks using a long-acting LA + WALANT technique using a short-term LA with epinephrine a vasoconstrictor agent	Procedure: TRONC 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. Procedure: WALANT 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. Drug: Ropivacaine troncular blocks with Ropivacaine 3.75 mg/ml Drug: Lidocaine + Epinephrine WALANT technique with 1% lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine

Arm

Intervention/Treatment

Active Comparator: CONTROL

Troncular blocks using a long-acting LA + Tourniquet

Procedure: TRONC

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.

Procedure: Tourniquet

inflation pressure 75 to 100 mmHg above systolic blood pressure.

Drug: Ropivacaine

troncular blocks with Ropivacaine 3.75 mg/ml

Experimental: WALANT

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

Procedure: TRONC

Procedure: WALANT

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.

Drug: Ropivacaine

troncular blocks with Ropivacaine 3.75 mg/ml

Drug: Lidocaine + Epinephrine

WALANT technique with 1% lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine

Outcome Measures

Primary Outcome Measures

Patient comfort during CTR [4 hours]
Pain score using a Visual Analogue Sclae (VAS) ranging from 0 to 10 (0= completely painless, 10= extremely painfull).

Secondary Outcome Measures

Quality of the endoscopic surgical procedure [4 hours]
Numeric Rating Scale (NRS) for visualization during endoscopic surgery ranging from 0 to 5 ( 0=very poor conditions; 5=optimal conditions)
Troncular block success [30 minutes]
Sensory perception to pin-prick on the specific territories of the median, ulnar and radial nerves at 10, 20 and 30 minutes post injection using a 3-point rating: 0 = absence of block (sharp sensation to pinprick), 1 = analgesia (dull sensation to pinprick), 2 = anesthesia (loss of sensation to pinprick)The need for an additional block, an intraoperative surgical infiltration or a sedation will be noted.
WALANT technique success [30 minutes]
Modification (or not) of the skin color near the injection area at 10, 20 and 30 minutes postinjection.
Hemostasis quality for the WALANT group [4 hours]
Usage (or not) of tourniquet.
Patient satisfaction [4 hours]
Patient satisfaction score collected in post-anesthesia care unit (PACU) using a Numeric Rating Scale (NRS-Satisfaction) ranging from 0 (very unsatisfied) to 10 (very satisfied).
Surgery duration [4 hours]
Time (in minutes) between the skin incision and the last suture.
Rate of complications [20 days]
Incidence of complications related to RA procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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