Carpal TunnelNCT04924348
WALANT Procedure in Carpal Tunnel Release
A study testing Experimental: WALANT procedure, Active Comparator: Axial ALR and Active Comparator: Truncal ALR in people with Carpal Tunnel and Median Nerve Neuralgia, run by Elsan at 1 site in France.
Trial summary
The possible benefits expected from the use of the WALANT procedure are a decrease in intraoperative pain at the surgical site, a decrease in hospitalization time, and a decrease in the time required to lift the anesthesia postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Carpal Tunnel, Median Nerve Neuralgia, Anesthesia, Local
- What is being tested?
- Experimental: WALANT procedure, Active Comparator: Axial ALR and Active Comparator: Truncal ALR
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2020to 25 Jan 2023
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient over 18 years of age
- Membership in a mandatory health insurance plan
- Patient treated for a first median nerve liberation surgery at the carpal tunnel
- Patient having been informed of the study and having given informed consent
- French-speaking patient
Who cannot join
- Surgical revision
- Contraindication(s) to loco-regional anesthesia :
- Coagulation disorder or ongoing anticoagulant therapy
- Existing peripheral neuropathy
- Amide-type AL allergy
- Pregnant or breastfeeding women
Show all 10Show fewer
- Inability to undergo the medical follow-up of the study for geographical, social or psychological reasons
- Patients under legal protection
- Patients under the influence of drugs that may interfere with the anesthetic techniques under study (cocaine, cannabis, etc. as judged by the investigator)
- Inclusion of the subject in another research protocol during this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WALANT (Wide Awake Local Anaesthesia With No Tourniquet) Procedure in Carpal Tunnel Release: a Prospective Randomized Study
The possible benefits expected from the use of the WALANT procedure are a decrease in intraoperative pain at the surgical site, a decrease in hospitalization time, and a decrease in the time required to lift the anesthesia postoperatively.
The risks identified are those inherent to each type of anesthesia (WALANT or traditional ALR), as encountered in current practice, and are therefore not specific to the study: risks related to the local anesthetic agent or risks related to the puncture procedure.
The main objective is to determine whether the patient's intraoperative pain at the surgical site is less after a WALANT procedure compared to a traditional ALR procedure (axillary or trunk).
Read the detailed description
Median nerve neurolysis at the carpal tunnel is one of the most performed procedures in the world. The use of loco-regional anesthesia (LRA) is common practice for this surgery, especially since the use of ultrasound guidance, which allows visualization of the nerves and control of the injection of anesthetic products, makes it a safe technique. The nerve blocks most commonly used in hand surgery are axillary blocks and truncal blocks. The choice between these two techniques, which are equivalent in terms of effectiveness and duration of anesthesia, depends in practice on the habits of each practitioner. As the use of a pneumatic tourniquet during the operation is systematic, the axillary block, by anaesthetizing the whole arm, avoids the discomfort described by some patients when using a tourniquet. For others, the discomfort is related to the sensation of a "dead arm" with a duration of anesthesia of several hours, which the truncular block makes it possible to avoid.
Recently, an alternative to traditional LRA by local anesthesia without tourniquet and without sedation (WALANT procedure: Wide Awake Local Anesthesia with No Tourniquet) has been described. Several studies show the efficacy and safety of this procedure, which is already used in current practice.
However, to date, there is no comparative study evaluating the effectiveness of the WALANT procedure compared to traditional hand surgery techniques for carpal tunnel, neither published nor in progress. This is the purpose of this study.
The WALANT technique, performed under ultrasound, includes two punctures.
- The first is a puncture through a medial approach above the wrist and includes two injections. A first subcutaneous injection reproducing a bar above the wrist flexion line, and a second injection above the median nerve. The volumes injected vary from 8 to 10 milliliters (ml).
- The second puncture is performed at the base of the palmar surface of the hand and consists of a 10 ml subcutaneous injection of the local anesthetic in order to take advantage of the vasoconstrictive effects of adrenaline, thus allowing the surgical procedure to be performed without a pneumatic tourniquet.
- Conditions
- Carpal Tunnel, Median Nerve Neuralgia, Anesthesia, Local
- Being tested
- Experimental: WALANT procedure, Active Comparator: Axial ALR, Active Comparator: Truncal ALR
- Medical subject headings
- Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: WALANT procedureProcedure or surgery
The WALANT technique, performed under ultrasound, includes two punctures.
- The first is a puncture through a medial approach above the wrist and includes two injections. A first subcutaneous injection reproducing a bar above the wrist flexion line, and a second injection above the median nerve. The volumes injected vary from 8 to 10 milliliters (ml).
- The second puncture is performed at the base of the palmar surface of the hand and consists of a 10 ml subcutaneous injection of the local anesthetic in order to take advantage of the vasoconstrictive effects of adrenaline, thus allowing the surgical procedure to be performed without a pneumatic tourniquet.
Active Comparator: Axial ALRProcedure or surgery
The anesthetic protocol in the axillary block consists of performing a puncture, using a needle (50 mm 22G with a short bevel), under the armpit at the level of the axillary hollow after skin disinfection. This puncture, performed under ultrasound, allows the injection of the local anesthetic around the median, radial, ulnar and musculocutaneous nerves. The volume injected per nerve can vary from 5 to 8 ml depending on the visual appreciation during the injection.
Active Comparator: Truncal ALRProcedure or surgery
The anesthetic protocol in truncal block consists in injecting the local anesthetic around the median and ulnar nerves by a puncture performed at the elbow or forearm (depending on the practitioner's experience). The volumes injected remain the same and the puncture is also performed under ultrasound guidance. Additional local anesthesia is administered by injecting an additional 5 ml above the wrist flexion line to block the sensory territory of the musculocutaneous nerve.
| Study group | Role | What they receive |
|---|---|---|
| WALANT procedure | Experimental | Local anesthesia of the WALANT type Receives: Procedure: Experimental: WALANT procedure |
| Axial ALR | Active comparator | Axillary loco-regional anesthesia Receives: Procedure: Active Comparator: Axial ALR |
| Truncal ALR | Active comparator | Truncal loco-regional anesthesia Receives: Procedure: Active Comparator: Truncal ALR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the patient's pain intraoperatively at the surgical site.
Evaluation of the patient's pain, at the level of the operative site by a visual analog scale from 0 to 10 where 0 equals to "No Pain" and 10 equals to "Extremely severe pain".
Measured: Within 24 hours after intervention
Secondary outcomes (21)
Visual Analog Scale for intraoperative pain at the surgical site
The assessment of pain at the surgical site will be evaluated using a 10-point visual analog scale score from 0 to 10 where 0 equals to "No Pain" and 10 equals to "Extremely severe pain"
Measured: intraoperative
Satisfaction scores
Satisfaction scores according to the forms provided in the appendices of the anaesthetist and the surgeon
Measured: Within 24 hours after intervention
Satisfaction scores
Satisfaction scores according to the forms provided in the appendices of the patient
Measured: One day after intervention
Assessment of the patient's overall pain after surgery
Assessment of the patient's overall pain after surgery using a numerical scale (EN) from 0 to 10 where 0 equals to "No Pain" and 10 equals to "Extremely severe pain"
Measured: One day after intervention
Assessment of the patient's overall pain after surgery
Assessment of the patient's overall pain after surgery using a numerical scale (EN) from 0 to 10 where 0 equals to "No Pain" and 10 equals to "Extremely severe pain"
Measured: One month after intervention
Assessment of the patient's overall pain after surgery
Assessment of the patient's overall pain after surgery using a numerical scale (EN) from 0 to 10 where 0 equals to "No Pain" and 10 equals to "Extremely severe pain"
Measured: Three months after intervention
Assessment of the patient's overall pain after surgery
Assessment of the patient's overall pain after surgery using a numerical scale (EN) from 0 to 10 where 0 equals to "No Pain" and 10 equals to "Extremely severe pain"
Measured: Six months after intervention
Evaluation of the return to work after surgery
Evaluation thanks to the Quick-DASH Questionnaire from 0 to 100 where 0 equals to "No disability" and 100 equals to "Most severe disability and reduced function"
Measured: Within 24 hours after intervention
Evaluation of the return to work after surgery
Evaluation thanks to the Quick-DASH Questionnaire from 0 to 100 where 0 equals to "No disability" and 100 equals to "Most severe disability and reduced function"
Measured: One month after intervention
Evaluation of the return to work after surgery
Evaluation thanks to the Quick-DASH Questionnaire from 0 to 100 where 0 equals to "No disability" and 100 equals to "Most severe disability and reduced function"
Measured: Three months after intervention
Evaluation of the return to work after surgery
Evaluation thanks to the Quick-DASH Questionnaire from 0 to 100 where 0 equals to "No disability" and 100 equals to "Most severe disability and reduced function"
Measured: Six months after intervention
Evaluation of the quality of life
Evaluation thanks to the SF-36 from 0 to 100 where 0 equals to "Poor Health" and 100 equals to "Good Health"
Measured: Baseline (Before the anesthesia)
Evaluation of the quality of life
Evaluation thanks to the SF-36 from 0 to 100 where 0 equals to "Poor Health" and 100 equals to "Good Health"
Measured: One month after intervention
Evaluation of the quality of life
Evaluation thanks to the SF-36 from 0 to 100 where 0 equals to "Poor Health" and 100 equals to "Good Health"
Measured: Three months after intervention
Evaluation of the quality of life
Evaluation thanks to the SF-36 from 0 to 100 where 0 equals to "Poor Health" and 100 equals to "Good Health"
Measured: Six months after intervention
Evaluation of the use of analgesics in the postoperative situation
The use of analgesics will be collected until D+1 by defining the following levels of analgesic intake:
- Level I: use of a paracetamol-type analgesic, up to 4 g/day
- Level II: use of another type of analgesic (Tramadol or Lamaline®)
Measured: One day after intervention
Evaluation of the failure rates of different anesthesia procedures.
The following were considered procedural failures: need for intravenous sedation for all 3 groups, need to inflate the tourniquet (applied as a preventive measure) for the WALANT group only.
Measured: Within 24 hours after intervention
Evaluation of the operative time.
Operating time defined as the time from skin incision to skin closure (in minutes)
Measured: During surgery
Evaluation of the hospitalization length.
Hospitalization length defined as the time from the patient's admission to the end of the hospitalization (in hours)
Measured: Within 24 hours after intervention
Evaluation of the time to release of anesthesia.
Time to release of anesthesia defined as the time from the placement of anesthesia to the release of motor (ability to clench/unclench the hand) and sensory (disappearance of tingling) anesthesia
Measured: Within 24 hours after intervention
Evaluation of the safety of different types of anesthesia.
Collection of postoperative adverse events.
Measured: One month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start2 Dec 2020
- Primary completion15 Feb 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Carpal TunnelStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, prospective, therapeutic, comparative, randomized controlled open-label, non-inferiority, single-center, national study.
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flore-Anne LECOQ, MD, Principal investigator, Institut de la Main Nantes Atlantique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924348
- Sponsor's protocol ID
- WALANT
- Other IDs
- 2020-A00446-33
- Status last verified
- Mar 2023
- First submitted
- 24 May 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lalonde DH. Conceptual origins, current practice, and views of wide awake hand surgery. J Hand Surg Eur Vol. 2017 Nov;42(9):886-895. doi: 10.1177/1753193417728427. Epub 2017 Sep 8.
PubMed 28886668Tulipan JE, Kim N, Abboudi J, Jones C, Liss F, Kirkpatrick W, Rivlin M, Wang ML, Matzon J, Ilyas AM. Open Carpal Tunnel Release Outcomes: Performed Wide Awake versus with Sedation. J Hand Microsurg. 2017 Aug;9(2):74-79. doi: 10.1055/s-0037-1603200. Epub 2017 May 22.
PubMed 28867906Lalonde D, Martin A. Tumescent local anesthesia for hand surgery: improved results, cost effectiveness, and wide-awake patient satisfaction. Arch Plast Surg. 2014 Jul;41(4):312-6. doi: 10.5999/aps.2014.41.4.312. Epub 2014 Jul 15.
PubMed 25075350Steiner MM, Calandruccio JH. Use of Wide-awake Local Anesthesia No Tourniquet in Hand and Wrist Surgery. Orthop Clin North Am. 2018 Jan;49(1):63-68. doi: 10.1016/j.ocl.2017.08.008.
PubMed 29145985Wright J, MacNeill AL, Mayich DJ. A prospective comparison of wide-awake local anesthesia and general anesthesia for forefoot surgery. Foot Ankle Surg. 2019 Apr;25(2):211-214. doi: 10.1016/j.fas.2017.10.015. Epub 2017 Nov 6.
PubMed 29409279Fayad F, Lefevre-Colau MM, Gautheron V, Mace Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Revel M, Poiraudeau S. Reliability, validity and responsiveness of the French version of the questionnaire Quick Disability of the Arm, Shoulder and Hand in shoulder disorders. Man Ther. 2009 Apr;14(2):206-12. doi: 10.1016/j.math.2008.01.013. Epub 2008 Apr 23.
PubMed 18436467Estebe JP, Gentili ME, Langlois G, Mouilleron P, Bernard F, Ecoffey C. Lidocaine priming reduces tourniquet pain during intravenous regional anesthesia: A preliminary study. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):120-3. doi: 10.1053/rapm.2003.50123.
PubMed 12677622
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WALANT (Wide Awake Local Anaesthesia With No Tourniquet) Procedure in Carpal Tunnel Release: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04924348
- Acronym / sponsor ID
- WALANT
- Conditions
- Carpal Tunnel, Median Nerve Neuralgia, Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 14 Jun 2021 (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 possible benefits expected from the use of the WALANT procedure are a decrease in intraoperative pain at the surgical site, a decrease in hospitalization time, and a decrease in the time required to lift the anesthesia postoperatively.
The risks identified are those inherent to each type of anesthesia (WALANT or traditional ALR), as encountered in current practice, and are therefore not specific to the study: risks related to the local anesthetic agent or risks related to the puncture procedure.
The main objective is to determine whether the patient's intraoperative pain at the surgical site is less after a WALANT procedure compared to a traditional ALR procedure (axillary or trunk).
Detailed description
Median nerve neurolysis at the carpal tunnel is one of the most performed procedures in the world. The use of loco-regional anesthesia (LRA) is common practice for this surgery, especially since the use of ultrasound guidance, which allows visualization of the nerves and control of the injection of anesthetic products, makes it a safe technique. The nerve blocks most commonly used in hand surgery are axillary blocks and truncal blocks. The choice between these two techniques, which are equivalent in terms of effectiveness and duration of anesthesia, depends in practice on the habits of each practitioner. As the use of a pneumatic tourniquet during the operation is systematic, the axillary block, by anaesthetizing the whole arm, avoids the discomfort described by some patients when using a tourniquet. For others, the discomfort is related to the sensation of a "dead arm" with a duration of anesthesia of several hours, which the truncular block makes it possible to avoid.
Recently, an alternative to traditional LRA by local anesthesia without tourniquet and without sedation (WALANT procedure: Wide Awake Local Anesthesia with No Tourniquet) has been described. Several studies show the efficacy and safety of this procedure, which is already used in current practice.
However, to date, there is no comparative study evaluating the effectiveness of the WALANT procedure compared to traditional hand surgery techniques for carpal tunnel, neither published nor in progress. This is the purpose of this study.
The WALANT technique, performed under ultrasound, includes two punctures.
- The first is a puncture through a medial approach above the wrist and includes two injections. A first subcutaneous injection reproducing a bar above the wrist flexion line, and a second injection above the median nerve. The volumes injected vary from 8 to 10 milliliters (ml).
- The second puncture is performed at the base of the palmar surface of the hand and consists of a 10 ml subcutaneous injection of the local anesthetic in order to take advantage of the vasoconstrictive effects of adrenaline, thus allowing the surgical procedure to be performed without a pneumatic tourniquet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional, prospective, therapeutic, comparative, randomized controlled open-label, non-inferiority, single-center, national study.
| Arm | Type | Receives |
|---|---|---|
| WALANT procedure | Experimental | Procedure: Experimental: WALANT procedureLocal anesthesia of the WALANT type |
| Axial ALR | Active comparator | Procedure: Active Comparator: Axial ALRAxillary loco-regional anesthesia |
| Truncal ALR | Active comparator | Procedure: Active Comparator: Truncal ALRTruncal loco-regional anesthesia |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patient over 18 years of age
- Membership in a mandatory health insurance plan
- Patient treated for a first median nerve liberation surgery at the carpal tunnel
- Patient having been informed of the study and having given informed consent
- French-speaking patient
Key exclusion criteria (10 listed)
- Surgical revision
- Contraindication(s) to loco-regional anesthesia :
- Pregnant or breastfeeding women
- Inability to undergo the medical follow-up of the study for geographical, social or psychological reasons
- Patients under legal protection
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 |
|---|---|---|
| Experimental: WALANT procedureThe WALANT technique, performed under ultrasound, includes two punctures. * The first is a puncture through a medial approach above the wrist and includes two injections. A first subcutaneous injection reproducing a bar above the wrist flexion line, and a second injection above the median nerve. The volumes injected vary from 8 to 10 milliliters (ml). * The second puncture is performed at the base of the palmar surface of the hand and consists of a 10 ml subcutaneous injection of the local anesthetic in order to take advantage of the vasoconstrictive effects of adrenaline, thus allowing the surgical procedure to be performed without a pneumatic tourniquet. | Procedure or surgery | WALANT procedure |
| Active Comparator: Axial ALRThe anesthetic protocol in the axillary block consists of performing a puncture, using a needle (50 mm 22G with a short bevel), under the armpit at the level of the axillary hollow after skin disinfection. This puncture, performed under ultrasound, allows the injection of the local anesthetic around the median, radial, ulnar and musculocutaneous nerves. The volume injected per nerve can vary from 5 to 8 ml depending on the visual appreciation during the injection. | Procedure or surgery | Axial ALR |
| Active Comparator: Truncal ALRThe anesthetic protocol in truncal block consists in injecting the local anesthetic around the median and ulnar nerves by a puncture performed at the elbow or forearm (depending on the practitioner's experience). The volumes injected remain the same and the puncture is also performed under ultrasound guidance. Additional local anesthesia is administered by injecting an additional 5 ml above the wrist flexion line to block the sensory territory of the musculocutaneous nerve. | Procedure or surgery | Truncal ALR |
Primary outcome
Evaluation of the patient's pain intraoperatively at the surgical site.
Time frame: Within 24 hours after intervention
Evaluation of the patient's pain, at the level of the operative site by a visual analog scale from 0 to 10 where 0 equals to "No Pain" and 10 equals to "Extremely severe pain".
21 secondary outcomes
Visual Analog Scale for intraoperative pain at the surgical site
Time frame: intraoperative
Satisfaction scores
Time frame: Within 24 hours after intervention
Satisfaction scores
Time frame: One day after intervention
Assessment of the patient's overall pain after surgery
Time frame: One day after intervention
Assessment of the patient's overall pain after surgery
Time frame: One month after intervention
Assessment of the patient's overall pain after surgery
Time frame: Three months after intervention
Assessment of the patient's overall pain after surgery
Time frame: Six months after intervention
Evaluation of the return to work after surgery
Time frame: Within 24 hours after intervention
Evaluation of the return to work after surgery
Time frame: One month after intervention
Evaluation of the return to work after surgery
Time frame: Three months after intervention
Evaluation of the return to work after surgery
Time frame: Six months after intervention
Evaluation of the quality of life
Time frame: Baseline (Before the anesthesia)
Evaluation of the quality of life
Time frame: One month after intervention
Evaluation of the quality of life
Time frame: Three months after intervention
Evaluation of the quality of life
Time frame: Six months after intervention
Evaluation of the use of analgesics in the postoperative situation
Time frame: One day after intervention
Evaluation of the failure rates of different anesthesia procedures.
Time frame: Within 24 hours after intervention
Evaluation of the operative time.
Time frame: During surgery
Evaluation of the hospitalization length.
Time frame: Within 24 hours after intervention
Evaluation of the time to release of anesthesia.
Time frame: Within 24 hours after intervention
Evaluation of the safety of different types of anesthesia.
Time frame: One month after intervention
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 10 Mar 2023.
- Background: PubMed 28886668Lalonde DH. Conceptual origins, current practice, and views of wide awake hand surgery. J Hand Surg Eur Vol. 2017 Nov;42(9):886-895. doi: 10.1177/1753193417728427. Epub 2017 Sep 8.
- Background: PubMed 28867906Tulipan JE, Kim N, Abboudi J, Jones C, Liss F, Kirkpatrick W, Rivlin M, Wang ML, Matzon J, Ilyas AM. Open Carpal Tunnel Release Outcomes: Performed Wide Awake versus with Sedation. J Hand Microsurg. 2017 Aug;9(2):74-79. doi: 10.1055/s-0037-1603200. Epub 2017 May 22.
- Background: PubMed 25075350Lalonde D, Martin A. Tumescent local anesthesia for hand surgery: improved results, cost effectiveness, and wide-awake patient satisfaction. Arch Plast Surg. 2014 Jul;41(4):312-6. doi: 10.5999/aps.2014.41.4.312. Epub 2014 Jul 15.
- Background: PubMed 29145985Steiner MM, Calandruccio JH. Use of Wide-awake Local Anesthesia No Tourniquet in Hand and Wrist Surgery. Orthop Clin North Am. 2018 Jan;49(1):63-68. doi: 10.1016/j.ocl.2017.08.008.
- Background: PubMed 29409279Wright J, MacNeill AL, Mayich DJ. A prospective comparison of wide-awake local anesthesia and general anesthesia for forefoot surgery. Foot Ankle Surg. 2019 Apr;25(2):211-214. doi: 10.1016/j.fas.2017.10.015. Epub 2017 Nov 6.
- Background: PubMed 18436467Fayad F, Lefevre-Colau MM, Gautheron V, Mace Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Revel M, Poiraudeau S. Reliability, validity and responsiveness of the French version of the questionnaire Quick Disability of the Arm, Shoulder and Hand in shoulder disorders. Man Ther. 2009 Apr;14(2):206-12. doi: 10.1016/j.math.2008.01.013. Epub 2008 Apr 23.
- Background: PubMed 12677622Estebe JP, Gentili ME, Langlois G, Mouilleron P, Bernard F, Ecoffey C. Lidocaine priming reduces tourniquet pain during intravenous regional anesthesia: A preliminary study. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):120-3. doi: 10.1053/rapm.2003.50123.
- Points to consider on multiplicity issues in clinical trials, EMEA, 2002Link provided by the sponsor.
- 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.
Flore-Anne LECOQ, MD principal investigator
Institut de la Main Nantes Atlantique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: WALANT procedure, Active Comparator: Axial ALR and Active Comparator: Truncal ALR in people with Carpal Tunnel and Median Nerve Neuralgia, run by Elsan 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 5 inclusion and 10 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 10 Mar 2023. 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?
Evaluation of the patient's pain intraoperatively at the surgical site. (time frame: Within 24 hours after intervention). 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 NCT04924348, which also lists 7 linked publications.
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 10 Mar 2023.