WALANT Procedure in Carpal Tunnel Release

Anesthesia, Local Clinical Trial

Official title:

WALANT (Wide Awake Local Anaesthesia With No Tourniquet) Procedure in Carpal Tunnel Release: a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924348
• Other study ID #: WALANT
• Secondary ID: 2020-A00446-33
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: January 25, 2023

Study information

• Verified date: March 2023
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 25, 2023
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Surgical revision

• Contraindication(s) to loco-regional anesthesia :

1. Coagulation disorder or ongoing anticoagulant therapy

2. Existing peripheral neuropathy

3. Amide-type AL allergy

• Pregnant or breastfeeding women

• 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

Related Conditions & MeSH terms

• Anesthesia, Local
• Carpal Tunnel
• Carpal Tunnel Syndrome
• Median Neuropathy
• Neuralgia

Intervention

Procedure:
• Experimental: WALANT procedure
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 ALR
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 ALR
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.

Locations

Country	Name	City	State
France	Institut de la main Nantes Atlantique	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

References & Publications (7)

Estebe 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. — View Citation

Fayad 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. — View Citation

Lalonde 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. — View Citation

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. — View Citation

Steiner 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. — View Citation

Tulipan 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. — View Citation

Wright 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	Within 24 hours after intervention
Secondary	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"	intraoperative
Secondary	Satisfaction scores	Satisfaction scores according to the forms provided in the appendices of the anaesthetist and the surgeon	Within 24 hours after intervention
Secondary	Satisfaction scores	Satisfaction scores according to the forms provided in the appendices of the patient	One day after intervention
Secondary	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"	One day after intervention
Secondary	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"	One month after intervention
Secondary	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"	Three months after intervention
Secondary	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"	Six months after intervention
Secondary	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"	Within 24 hours after intervention
Secondary	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"	One month after intervention
Secondary	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"	Three months after intervention
Secondary	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"	Six months after intervention
Secondary	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"	Baseline (Before the anesthesia)
Secondary	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"	One month after intervention
Secondary	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"	Three months after intervention
Secondary	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"	Six months after intervention
Secondary	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®)	One day after intervention
Secondary	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.	Within 24 hours after intervention
Secondary	Evaluation of the operative time.	Operating time defined as the time from skin incision to skin closure (in minutes)	During surgery
Secondary	Evaluation of the hospitalization length.	Hospitalization length defined as the time from the patient's admission to the end of the hospitalization (in hours)	Within 24 hours after intervention
Secondary	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	Within 24 hours after intervention
Secondary	Evaluation of the safety of different types of anesthesia.	Collection of postoperative adverse events.	One month after intervention

External Links

•   Points to consider on multiplicity issues in clinical trials, EMEA, 2002