- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07617064
WALANT Versus Local Anesthesia With Tourniquet for Carpal Tunnel Decompression (WALANT vs LA-T)
Intraoperative Pain During Carpal Tunnel Release: Wide-Awake Local Anesthesia No Tourniquet Versus Local Anesthesia and Tourniquet - A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Al-Azhar University Hospital (Neurosurgery Department)
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Giza, Egypt
- Misr University for Science and Technology Hospital (Orthopedic Surgery Department)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (≥18 years) with clinically and electrophysiologically confirmed carpal tunnel syndrome.
Candidate for surgical treatment with open carpal tunnel decompression.
American Society of Anesthesiologists (ASA) physical status I or II.
Able and willing to provide written informed consent.
Exclusion Criteria:
- Surgery-related anxiety requiring sedation or general anesthesia.
Known contraindication or allergy to lidocaine or epinephrine.
Active local or systemic infection at or near the surgical site.
ASA physical status III or higher.
Pregnancy or breastfeeding.
Any condition preventing reliable pain scoring or follow-up according to investigator judgment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: WALANT (Wide-Awake Local Anesthesia No Tourniquet)
"Patients received wide-awake local anesthesia with epinephrine infiltration in the operative field, without arm tourniquet or routine sedation, for open carpal tunnel decompression."
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"Twenty milliliters of 1% lidocaine (200 mg) with epinephrine 1:100,000, buffered with 8.4% sodium bicarbonate at a 10:1 ratio, were infiltrated into the operative field approximately 20 minutes before incision.
No tourniquet was applied.
A mini-open CTD through a 2-3 cm incision was performed in a minor procedure room under full aseptic technique.
Hemostasis relied on epinephrine-mediated vasoconstriction and meticulous surgery."
|
|
Active Comparator: Local Anesthesia With Tourniquet (LA-T)
"Patients received buffered lidocaine without epinephrine and an upper-arm pneumatic tourniquet for open carpal tunnel decompression."
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"Twenty milliliters of 1% lidocaine (200 mg) buffered identically to the WALANT solution but without epinephrine were infiltrated approximately 5 minutes before incision in the operating room.
A blood pressure cuff tourniquet was placed above the elbow, inflated to 100 mmHg above systolic pressure after arm elevation and draping, and released after wound closure.
Mini-open CTD was performed through a 2-3 cm incision under standard aseptic conditions."
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative Pain (VAS)
Time Frame: Intraoperative.
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"Overall intraoperative pain scored by the patient using a visual analog scale (VAS) from 0 (no pain) to 10 (worst imaginable pain).
The patient rated the overall pain experienced during surgery on a standardized questionnaire administered by a blinded assessor."
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Intraoperative.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infiltration Pain (VAS)
Time Frame: Perioperative " During local anesthetic injection, assessed immediately after infiltration."
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"Pain at the time of local anesthetic infiltration, scored on a VAS 0-10."
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Perioperative " During local anesthetic injection, assessed immediately after infiltration."
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Tourniquet Pain (VAS) - LA-T Group Only
Time Frame: Perioperative " During tourniquet inflation, assessed after the primary intraoperative pain rating."
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"Tourniquet-specific pain in the LA-T group, scored on VAS 0-10, recorded separately from overall intraoperative pain."
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Perioperative " During tourniquet inflation, assessed after the primary intraoperative pain rating."
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Operative Time
Time Frame: Intraoperative (from first skin incision to final skin closure).
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"Operative time in minutes, recorded from incision to completion of skin closure."
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Intraoperative (from first skin incision to final skin closure).
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Patient Satisfaction With Operating Room Experience
Time Frame: Day 1 Postoperative
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"Global patient satisfaction with the operating room experience, assessed using a numeric rating scale from 0 (not satisfied) to 10 (fully satisfied)."
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Day 1 Postoperative
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Intraoperative Complications
Time Frame: Baseline up to 30 days postoperatively.
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"Any deviation from the normal operative course, including bleeding requiring intervention, nerve injury, or other intraoperative adverse events, captured on the standardized operative record and postoperative questionnaire."
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Baseline up to 30 days postoperatively.
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Collaborators and Investigators
Investigators
- Principal Investigator: Mohammed S.K. Hamza, MD, PhD, Faculty of Medicine, Misr University for Science and Technology, Giza, Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Median Neuropathy
- Mononeuropathies
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Carpal Tunnel Syndrome
- Patient Satisfaction
- Equipment and Supplies
- Anesthesia and Analgesia
- Anesthesia, Conduction
- Anesthesia
- Anesthesia, Local
- Tourniquets
Other Study ID Numbers
- WALANTvsLAT-CTD-RCT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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