Carpal Tunnel ReleaseWALANCT04494100
WALANT Technique (Wide Awake Local Anesthesia No Tourniquet) for Carpal Tunnel Release.
A study testing TRONC, WALANT and Tourniquet in people with Carpal Tunnel Release, run by CMC Ambroise Paré at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Release
- What is being tested?
- TRONC, WALANT and Tourniquet
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Sep 2020to 5 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing endoscopic carpal tunnel release
- Consent for participation
- Affiliation to a social security system
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique Jouvenet
Paris, Île-de-France Region, 75016
Clinique Rémusat
Paris, Île-de-France Region, 75016
About this study
Official title: WALANT Technique (Wide Awake Local Anesthesia No Tourniquet) in Association With Analgesic Troncular Blocks at the Wirst for Carpal Tunnel Release.
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.
Read more
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.
Read the 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
- Conditions
- Carpal Tunnel Release
- Being tested
- TRONC, WALANT, Tourniquet, Ropivacaine, Lidocaine + Epinephrine
- Keywords
- WALANT, Tourniquet, Regional anesthesia, Troncular blocks, Postoperative Analgesia, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRONCProcedure or surgery
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.
WALANTProcedure or surgery
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.
TourniquetProcedure or surgery
inflation pressure 75 to 100 mmHg above systolic blood pressure.
RopivacaineDrug
troncular blocks with Ropivacaine 3.75 mg/ml
Lidocaine + EpinephrineDrug
WALANT technique with 1% lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Active comparator | Troncular blocks using a long-acting LA + Tourniquet Receives: Procedure: TRONC; Procedure: Tourniquet; Drug: Ropivacaine |
| WALANT | Experimental | Troncular blocks using a long-acting LA + WALANT technique using a short-term LA with epinephrine a vasoconstrictor agent Receives: Procedure: TRONC; Procedure: WALANT; Drug: Ropivacaine; Drug: Lidocaine + Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort during CTR
Pain score using a Visual Analogue Sclae (VAS) ranging from 0 to 10 (0= completely painless, 10= extremely painfull).
Measured: 4 hours
Secondary outcomes (7)
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)
Measured: 4 hours
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.
Measured: 30 minutes
WALANT technique success
Modification (or not) of the skin color near the injection area at 10, 20 and 30 minutes postinjection.
Measured: 30 minutes
Hemostasis quality for the WALANT group
Usage (or not) of tourniquet.
Measured: 4 hours
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).
Measured: 4 hours
Surgery duration
Time (in minutes) between the skin incision and the last suture.
Measured: 4 hours
Rate of complications
Incidence of complications related to RA procedure
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start11 Sep 2020
- Primary completion25 Jun 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel ReleaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494100
- Sponsor's protocol ID
- 2020/02
- Acronym
- WALA
- Status last verified
- Apr 2026
- First submitted
- 28 Jul 2020
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37031817
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WALANT Technique (Wide Awake Local Anesthesia No Tourniquet) in Association With Analgesic Troncular Blocks at the Wirst for Carpal Tunnel Release.
- ClinicalTrials.gov ID
- NCT04494100
- Acronym / sponsor ID
- WALA / 2020/02
- Conditions
- Carpal Tunnel Release
- Keywords
- WALANT, Tourniquet, Regional anesthesia, Troncular blocks, Postoperative Analgesia, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Active comparator | Procedure: TRONC, Procedure: Tourniquet, Drug: RopivacaineTroncular blocks using a long-acting LA + Tourniquet |
| WALANT | Experimental | Procedure: TRONC, Procedure: WALANT, Drug: Ropivacaine, Drug: Lidocaine + EpinephrineTroncular blocks using a long-acting LA + WALANT technique using a short-term LA with epinephrine a vasoconstrictor agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing endoscopic carpal tunnel release
- Consent for participation
- Affiliation to a social security system
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRONCinjection 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 or surgery | CONTROL, WALANT |
| WALANTinfiltration 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. | Procedure or surgery | WALANT |
| Tourniquetinflation pressure 75 to 100 mmHg above systolic blood pressure. | Procedure or surgery | CONTROL |
| Ropivacainetroncular blocks with Ropivacaine 3.75 mg/ml | Drug | CONTROL, WALANT |
| Lidocaine + EpinephrineWALANT technique with 1% lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine | Drug | WALANT |
Primary outcome
Patient comfort during CTR
Time frame: 4 hours
Pain score using a Visual Analogue Sclae (VAS) ranging from 0 to 10 (0= completely painless, 10= extremely painfull).
7 secondary outcomes
Quality of the endoscopic surgical procedure
Time frame: 4 hours
Troncular block success
Time frame: 30 minutes
WALANT technique success
Time frame: 30 minutes
Hemostasis quality for the WALANT group
Time frame: 4 hours
Patient satisfaction
Time frame: 4 hours
Surgery duration
Time frame: 4 hours
Rate of complications
Time frame: 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Results publication: PubMed 37031817Bloc 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRONC, WALANT and Tourniquet in people with Carpal Tunnel Release, run by CMC Ambroise Paré at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comfort during CTR (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04494100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.