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

Primary Purpose

Carpal Tunnel Release

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TRONC
WALANT
Tourniquet
Ropivacaine
Lidocaine + Epinephrine
Sponsored by
CMC Ambroise Paré
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Carpal Tunnel Release focused on measuring WALANT, Tourniquet, Regional anesthesia, Troncular blocks, Postoperative Analgesia, Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinique Jouvenet
  • Clinique Rémusat

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CONTROL

WALANT

Arm Description

Troncular blocks using a long-acting LA + Tourniquet

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

Outcomes

Primary Outcome Measures

Patient comfort during CTR
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
Numeric Rating Scale (NRS) for visualization during endoscopic surgery ranging from 0 to 5 ( 0=very poor conditions; 5=optimal conditions)
Troncular block success
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
Modification (or not) of the skin color near the injection area at 10, 20 and 30 minutes postinjection.
Hemostasis quality for the WALANT group
Usage (or not) of tourniquet.
Patient satisfaction
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
Time (in minutes) between the skin incision and the last suture.
Rate of complications
Incidence of complications related to RA procedure

Full Information

First Posted
July 28, 2020
Last Updated
July 21, 2021
Sponsor
CMC Ambroise Paré
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1. Study Identification

Unique Protocol Identification Number
NCT04494100
Brief Title
WALANT Technique (Wide Awake Local Anesthesia No Tourniquet) for Carpal Tunnel Release.
Acronym
WALA
Official Title
WALANT Technique (Wide Awake Local Anesthesia No Tourniquet) in Association With Analgesic Troncular Blocks at the Wirst for Carpal Tunnel Release.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
July 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CMC Ambroise Paré

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Release
Keywords
WALANT, Tourniquet, Regional anesthesia, Troncular blocks, Postoperative Analgesia, Ultrasound

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
Troncular blocks using a long-acting LA + Tourniquet
Arm Title
WALANT
Arm Type
Experimental
Arm Description
Troncular blocks using a long-acting LA + WALANT technique using a short-term LA with epinephrine a vasoconstrictor agent
Intervention Type
Procedure
Intervention Name(s)
TRONC
Intervention 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(s)
WALANT
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Tourniquet
Intervention Description
inflation pressure 75 to 100 mmHg above systolic blood pressure.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
troncular blocks with Ropivacaine 3.75 mg/ml
Intervention Type
Drug
Intervention Name(s)
Lidocaine + Epinephrine
Intervention Description
WALANT technique with 1% lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine
Primary Outcome Measure Information:
Title
Patient comfort during CTR
Description
Pain score using a Visual Analogue Sclae (VAS) ranging from 0 to 10 (0= completely painless, 10= extremely painfull).
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Quality of the endoscopic surgical procedure
Description
Numeric Rating Scale (NRS) for visualization during endoscopic surgery ranging from 0 to 5 ( 0=very poor conditions; 5=optimal conditions)
Time Frame
4 hours
Title
Troncular block success
Description
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.
Time Frame
30 minutes
Title
WALANT technique success
Description
Modification (or not) of the skin color near the injection area at 10, 20 and 30 minutes postinjection.
Time Frame
30 minutes
Title
Hemostasis quality for the WALANT group
Description
Usage (or not) of tourniquet.
Time Frame
4 hours
Title
Patient satisfaction
Description
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).
Time Frame
4 hours
Title
Surgery duration
Description
Time (in minutes) between the skin incision and the last suture.
Time Frame
4 hours
Title
Rate of complications
Description
Incidence of complications related to RA procedure
Time Frame
20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinique Jouvenet
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75016
Country
France
Facility Name
Clinique Rémusat
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75016
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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