NCT04494100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 11, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2021

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

July 28, 2020

Last Update Submit

April 2, 2026

Conditions

Keywords

WALANTTourniquetRegional anesthesiaTroncular blocksPostoperative AnalgesiaUltrasound

Outcome Measures

Primary Outcomes (1)

  • Patient comfort during CTR

    Pain score using a Visual Analogue Sclae (VAS) ranging from 0 to 10 (0= completely painless, 10= extremely painfull).

    4 hours

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

CONTROL

ACTIVE COMPARATOR

Troncular blocks using a long-acting LA + Tourniquet

Procedure: TRONCProcedure: TourniquetDrug: Ropivacaine

WALANT

EXPERIMENTAL

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

Procedure: TRONCProcedure: WALANTDrug: RopivacaineDrug: Lidocaine + Epinephrine

Interventions

TRONCPROCEDURE

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.

CONTROLWALANT
WALANTPROCEDURE

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.

WALANT
TourniquetPROCEDURE

inflation pressure 75 to 100 mmHg above systolic blood pressure.

CONTROL

troncular blocks with Ropivacaine 3.75 mg/ml

CONTROLWALANT

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

WALANT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing endoscopic carpal tunnel release
  • Consent for participation
  • Affiliation to a social security system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Jouvenet

Paris, Île-de-France Region, 75016, France

Location

Clinique Rémusat

Paris, Île-de-France Region, 75016, France

Location

Related Publications (1)

  • Bloc S, Squara P, Quemeneur C, Doirado M, Thomsen L, Merzoug M, Naudin C, Le Sache F. Wide Awake Local Anesthesia No Tourniquet (WALANT) technique improves the efficiency of distal nerve blocks for carpal tunnel release. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101229. doi: 10.1016/j.accpm.2023.101229. Epub 2023 Apr 7.

MeSH Terms

Interventions

TourniquetsRopivacaineLidocaineEpinephrine

Intervention Hierarchy (Ancestors)

Equipment and SuppliesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilidesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 31, 2020

Study Start

September 11, 2020

Primary Completion

June 25, 2021

Study Completion

July 5, 2021

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations