Carpal Tunnel SyndromeWALABNCT06040840
WALANT Versus Axillary Brachial Plexus Block in Carpal Tunnel Release
A study testing BAX, Tourniquet and Lidocaine in people with Carpal Tunnel Syndrome, run by CMC Ambroise Paré at 1 site in France.
Trial summary
Carpal tunnel syndrome (CTS) is a common medical condition that remains one of the most frequently reported forms of median nerve compression. Surgical procedure is a treatment option for CTS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- BAX, Tourniquet and Lidocaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2024to 28 Jan 2025
- 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
- Contraindication for regional anesthesia (truncal neuropathy, infection at the puncture site, coagulation disorder, …)
- Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, propofol, lidocaine, epinephrine)
- Chronic pain syndrome
- Preoperative Anxiety
- Pregnant or breastfeeding women
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WALANT Versus Axillary Brachial Plexus Block in Carpal Tunnel Release: a Non-inferiority Randomized Controlled Trial
Carpal tunnel syndrome (CTS) is a common medical condition that remains one of the most frequently reported forms of median nerve compression. Surgical procedure is a treatment option for CTS. For this surgery of the upper extremity, regional anesthesia (RA) is the strategy that should be systematically preferred because it is associated with shorter postanesthetic care and less pain compared to general anesthesia. Multiple approaches to block the brachial plexus are available for the surgery of the upper extremity below the elbow, but the axillary block (BAX) remains the most common approach as it is associated with low side effects.
One of the most significant recent advances in the surgery of the upper extremity has been the emergence of Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique. WALANT is an infiltration technique of a local anesthetic (LA) (lidocaine) and a hemostatic agent (epinephrine) directly into the operative site to induce anesthesia and hemostasis in the area of the surgical procedure to provide conditions suitable for hand surgery without sedation and tourniquet. Given its effectiveness and low side effects, WALANT could be a technique of choice in ambulatory surgery.
The main objective of this non-inferiority, prospective, randomized, open-label, parallel-group controlled trial is to assess the efficacy of WALANT technique compared to BAX in carpal tunnel release (CTR).
Read the detailed description
Randomization will be performed using an external Interactive Web Response System. Subjects will be randomly assigned (1:1) in permuted blocks of different sizes, to have either BAX (Control group) or WALANT (Interventional group). A stratification of the randomization will be planned according to the Sex.
In the BAX group (usual technique), axillary brachial plexus block will be performed. In the WALANT group (experimental technique), local anesthesia will be performed. The Peripheral nerve blocks (PNBs) will be performed by a physician not involved in the peri-operative assessment. Care providers and outcomes assessors will be blinded to group allocation.
After obtaining venous access and placement of standard monitors, patients will be administered oxygen 2 L/min via nasal prongs. Thirty minutes before surgery, an experienced anesthesiologist will perform the regional blocks guided by ultrasound (Sonosite Export, Bothell, USA) using an ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) as follow:
- In the BAX group, patients will be placed in a supine position with their arm abducted to 90°. The ultrasound probe will be placed to obtain a transverse image of the axillary artery at the level of the conjoint tendon of the latissimus dorsi and teres major muscles. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of lidocaine (10mg/ml) around the musculocutaneous, radial, median and ulnar nerves. 30 ml of the solution will be used to achieve the BAX.
- In the WALANT group, patients will be placed in a supine position. Solution for local anesthesia will be prepared using 20 ml of lidocaine (10mg/ml) with epinephrine (0.005 mg/ml), 17 ml of saline solution and 3 ml of 8.4% sodium bicarbonate. The ultrasound probe will be placed to obtain a transverse image of the median nerve at the wrist. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of 5 ml of the solution posterior and then anterior to the median nerve under the annular carpal ligament. Then the ultrasound probe will be placed to obtain a longitudinal image of the median nerve at the wrist. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of 15 ml of the solution anterior to the median nerve towards the carpal tunnel. At last, a local infiltration with 5 ml of the solution will be performed around the surgical incision.
Upon completion of the blocks, patients will be transferred to the operating room.
In the operating room, a pneumatic tourniquet will be placed on the upper arm in all patients and will be inflated in patients of "BAX" group only. In case of pain or discomfort, an anesthetist blinded to treatment arm will decide on the need for an alternative anesthetic technique.
In ward:
- Postoperative analgesia protocol: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day)
- Mobilization of patient
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- BAX, Tourniquet, Lidocaine, WALANT, Lidocaine + Epinephrine
- Keywords
- WALANT, Axillary block, Regional anesthesia, Tourniquet, Carpal Tunnel Release, Postoperative analgesia, Perioperative patient satisfaction
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAXProcedure or surgery
Injection of 30 mL of lidocaine (10 mg/ml) around the median, radial, ulnar and musculocutaneous nerves.
TourniquetProcedure or surgery
Inflation pressure 75 to 100 mmHg above the patient's systolic blood pressure.
LidocaineDrug
Axillary block with Lidocaine (10 mg/ml).
WALANTProcedure or surgery
Preparation of a mixture of 20 ml of lidocaine (10 mg/ml) with epinephrine (0.005 mg/ml) + 3 ml Na bicarbonate (84 mg/ml) + 17 ml sterile normal saline.
The ultrasound probe will be placed to obtain a transverse image of the median nerve at the wrist. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of 5 ml of the solution posterior and then anterior to the median nerve under the annular carpal ligament.
Then the ultrasound probe will be placed to obtain a longitudinal image of the median nerve at the wrist. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of 15 ml of the solution anterior to the median nerve towards the carpal tunnel.
At last, a local infiltration with 5 ml of the solution will be performed around the surgical incision.
Lidocaine + EpinephrineDrug
WALANT technique with lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine.
| Study group | Role | What they receive |
|---|---|---|
| BAX group | Active comparator | Axillary brachial plexus block + Tourniquet Receives: Procedure: BAX; Procedure: Tourniquet; Drug: Lidocaine |
| WALANT group | Experimental | Wide Awake Local Anesthesia No Tourniquet Receives: Procedure: WALANT; Drug: Lidocaine + Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional anesthesia success
Need (or not) for additional anesthetic procedure during surgery: analgesics, sedation, general anesthesia, local anesthetics
Measured: 2 hours
Secondary outcomes (7)
Surgery duration
Time (in minutes) between the skin incision and the wound dressing procedure.
Measured: 2 hours
Length of hospital stay
Time (in minutes) between ward admission and discharge.
Measured: 24 hours
Discharge criteria assessed by PADSS
Time (in minutes) between the regional anesthesia and the ability to discharge defined by the modified Post Anesthesia Discharge Scoring System (PADSS) who achieve a score of 9 or more.
Measured: 24 hours
Patient satisfaction assessed by EVAN-LR self-reported questionnaire
EVAN-LR self-reported questionnaire comprising 19 items structured in five dimensions, depending on their content: Attention (4 items), Information (5 items), Discomfort (4 items), Waiting (2 items), and Pain (4 items). Each item is linearly transformed to a 0-100 scale, with 100 indicating the best possible level of satisfaction and 0 the worst.
Measured: 24 hours
Postoperative pain at the surgical site assessed by VRS
Maximum postoperative pain at the surgical site will be assessed at Day-0 et at Day-1 using a Verbal Rating Scale (VRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain).
Measured: 24 hours
Surgical site bleeding
Surgeon's clear-field satisfactory score: 1=bloodless, 2=little blood, 3=bloody field but performable, 4=bloody field
Measured: 2 hours
Rate of complications
Incidence of complications related to RA procedure: vascular puncture, paresthesia, local anesthetic systemic toxicity
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start13 May 2024
- Primary completion27 Jan 2025
- Study completion28 Jan 2025
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 SyndromeStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 130 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
- NCT06040840
- Sponsor's protocol ID
- 2023/02
- Acronym
- WALAB
- Status last verified
- Apr 2026
- First submitted
- 7 Sep 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Virtos M, Chassery C, Marty P, Basset B, Casalprim J, Vuillaume C, De Lussy A, Atthar V, Naudin C, Joshi G, Rontes O. Wide awake local anesthesia no tourniquet (WALANT) versus ultrasound-guided axillary block in carpal tunnel release: a non-inferiority randomized controlled trial. Reg Anesth Pain Med. 2025 Nov 13:rapm-2025-107152. doi: 10.1136/rapm-2025-107152. Online ahead of print.
PubMed 41233154
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 Versus Axillary Brachial Plexus Block in Carpal Tunnel Release: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06040840
- Acronym / sponsor ID
- WALAB / 2023/02
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- WALANT, Axillary block, Regional anesthesia, Tourniquet, Carpal Tunnel Release, Postoperative analgesia, Perioperative patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 18 Sep 2023 (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.
Carpal tunnel syndrome (CTS) is a common medical condition that remains one of the most frequently reported forms of median nerve compression. Surgical procedure is a treatment option for CTS. For this surgery of the upper extremity, regional anesthesia (RA) is the strategy that should be systematically preferred because it is associated with shorter postanesthetic care and less pain compared to general anesthesia. Multiple approaches to block the brachial plexus are available for the surgery of the upper extremity below the elbow, but the axillary block (BAX) remains the most common approach as it is associated with low side effects.
One of the most significant recent advances in the surgery of the upper extremity has been the emergence of Wide-Awake Local Anesthesia No Tourniquet (WALANT) technique. WALANT is an infiltration technique of a local anesthetic (LA) (lidocaine) and a hemostatic agent (epinephrine) directly into the operative site to induce anesthesia and hemostasis in the area of the surgical procedure to provide conditions suitable for hand surgery without sedation and tourniquet. Given its effectiveness and low side effects, WALANT could be a technique of choice in ambulatory surgery.
The main objective of this non-inferiority, prospective, randomized, open-label, parallel-group controlled trial is to assess the efficacy of WALANT technique compared to BAX in carpal tunnel release (CTR).
Detailed description
Randomization will be performed using an external Interactive Web Response System. Subjects will be randomly assigned (1:1) in permuted blocks of different sizes, to have either BAX (Control group) or WALANT (Interventional group). A stratification of the randomization will be planned according to the Sex.
In the BAX group (usual technique), axillary brachial plexus block will be performed. In the WALANT group (experimental technique), local anesthesia will be performed. The Peripheral nerve blocks (PNBs) will be performed by a physician not involved in the peri-operative assessment. Care providers and outcomes assessors will be blinded to group allocation.
After obtaining venous access and placement of standard monitors, patients will be administered oxygen 2 L/min via nasal prongs. Thirty minutes before surgery, an experienced anesthesiologist will perform the regional blocks guided by ultrasound (Sonosite Export, Bothell, USA) using an ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) as follow:
- In the BAX group, patients will be placed in a supine position with their arm abducted to 90°. The ultrasound probe will be placed to obtain a transverse image of the axillary artery at the level of the conjoint tendon of the latissimus dorsi and teres major muscles. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of lidocaine (10mg/ml) around the musculocutaneous, radial, median and ulnar nerves. 30 ml of the solution will be used to achieve the BAX.
- In the WALANT group, patients will be placed in a supine position. Solution for local anesthesia will be prepared using 20 ml of lidocaine (10mg/ml) with epinephrine (0.005 mg/ml), 17 ml of saline solution and 3 ml of 8.4% sodium bicarbonate. The ultrasound probe will be placed to obtain a transverse image of the median nerve at the wrist. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of 5 ml of the solution posterior and then anterior to the median nerve under the annular carpal ligament. Then the ultrasound probe will be placed to obtain a longitudinal image of the median nerve at the wrist. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of 15 ml of the solution anterior to the median nerve towards the carpal tunnel. At last, a local infiltration with 5 ml of the solution will be performed around the surgical incision.
Upon completion of the blocks, patients will be transferred to the operating room.
In the operating room, a pneumatic tourniquet will be placed on the upper arm in all patients and will be inflated in patients of "BAX" group only. In case of pain or discomfort, an anesthetist blinded to treatment arm will decide on the need for an alternative anesthetic technique.
In ward:
- Postoperative analgesia protocol: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day)
- Mobilization of patient
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAX group | Active comparator | Procedure: BAX, Procedure: Tourniquet, Drug: LidocaineAxillary brachial plexus block + Tourniquet |
| WALANT group | Experimental | Procedure: WALANT, Drug: Lidocaine + EpinephrineWide Awake Local Anesthesia No Tourniquet |
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)
- Contraindication for regional anesthesia (truncal neuropathy, infection at the puncture site, coagulation disorder, …)
- Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, propofol, lidocaine, epinephrine)
- Chronic pain syndrome
- Preoperative Anxiety
- Pregnant or breastfeeding women
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 |
|---|---|---|
| BAXInjection of 30 mL of lidocaine (10 mg/ml) around the median, radial, ulnar and musculocutaneous nerves. | Procedure or surgery | BAX group |
| TourniquetInflation pressure 75 to 100 mmHg above the patient's systolic blood pressure. | Procedure or surgery | BAX group |
| LidocaineAxillary block with Lidocaine (10 mg/ml). | Drug | BAX group |
| WALANTPreparation of a mixture of 20 ml of lidocaine (10 mg/ml) with epinephrine (0.005 mg/ml) + 3 ml Na bicarbonate (84 mg/ml) + 17 ml sterile normal saline. The ultrasound probe will be placed to obtain a transverse image of the median nerve at the wrist. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of 5 ml of the solution posterior and then anterior to the median nerve under the annular carpal ligament. Then the ultrasound probe will be placed to obtain a longitudinal image of the median nerve at the wrist. With an in-plane technique, a 50mm ultrasound needle (Ultraplex 360°, B Braun, Melsungen, Germany) will be advanced to achieve a spread of 15 ml of the solution anterior to the median nerve towards the carpal tunnel. At last, a local infiltration with 5 ml of the solution will be performed around the surgical incision. | Procedure or surgery | WALANT group |
| Lidocaine + EpinephrineWALANT technique with lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine. | Drug | WALANT group |
Primary outcome
Regional anesthesia success
Time frame: 2 hours
Need (or not) for additional anesthetic procedure during surgery: analgesics, sedation, general anesthesia, local anesthetics
7 secondary outcomes
Surgery duration
Time frame: 2 hours
Length of hospital stay
Time frame: 24 hours
Discharge criteria assessed by PADSS
Time frame: 24 hours
Patient satisfaction assessed by EVAN-LR self-reported questionnaire
Time frame: 24 hours
Postoperative pain at the surgical site assessed by VRS
Time frame: 24 hours
Surgical site bleeding
Time frame: 2 hours
Rate of complications
Time frame: 24 hours
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 41233154Virtos M, Chassery C, Marty P, Basset B, Casalprim J, Vuillaume C, De Lussy A, Atthar V, Naudin C, Joshi G, Rontes O. Wide awake local anesthesia no tourniquet (WALANT) versus ultrasound-guided axillary block in carpal tunnel release: a non-inferiority randomized controlled trial. Reg Anesth Pain Med. 2025 Nov 13:rapm-2025-107152. doi: 10.1136/rapm-2025-107152. Online ahead of print.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAX, Tourniquet and Lidocaine in people with Carpal Tunnel Syndrome, run by CMC Ambroise Paré at 1 site 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 1 site 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?
Regional anesthesia success (time frame: 2 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 NCT06040840, 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.