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
1 other identifier
interventional
100
1 country
2
Brief Summary
This multicenter, randomized, double-blinded controlled trial compared two local anesthetic techniques for open carpal tunnel decompression in adults. The wide-awake local anesthesia no tourniquet (WALANT) technique uses lidocaine with epinephrine and no tourniquet, whereas the conventional technique uses lidocaine only with a pneumatic tourniquet (LA-T). One hundred adults with carpal tunnel syndrome were randomized 1:1 to WALANT or LA-T at two tertiary university hospitals in Egypt. The primary objective was to compare intraoperative pain during surgery. Secondary objectives included pain during infiltration, tourniquet pain (LA-T only), operative time, patient satisfaction, and intraoperative complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2025
CompletedFirst Submitted
Initial submission to the registry
May 17, 2026
CompletedFirst Posted
Study publicly available on registry
June 1, 2026
CompletedJune 1, 2026
May 1, 2026
1.3 years
May 17, 2026
May 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraoperative Pain (VAS)
"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."
Intraoperative.
Secondary Outcomes (5)
Infiltration Pain (VAS)
Perioperative " During local anesthetic injection, assessed immediately after infiltration."
Tourniquet Pain (VAS) - LA-T Group Only
Perioperative " During tourniquet inflation, assessed after the primary intraoperative pain rating."
Operative Time
Intraoperative (from first skin incision to final skin closure).
Patient Satisfaction With Operating Room Experience
Day 1 Postoperative
Intraoperative Complications
Baseline up to 30 days postoperatively.
Study Arms (2)
WALANT (Wide-Awake Local Anesthesia No Tourniquet)
EXPERIMENTAL"Patients received wide-awake local anesthesia with epinephrine infiltration in the operative field, without arm tourniquet or routine sedation, for open carpal tunnel decompression."
Local Anesthesia With Tourniquet (LA-T)
ACTIVE COMPARATOR"Patients received buffered lidocaine without epinephrine and an upper-arm pneumatic tourniquet for open carpal tunnel decompression."
Interventions
"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."
"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."
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Al-Azhar University Hospital (Neurosurgery Department)
Cairo, Egypt
Misr University for Science and Technology Hospital (Orthopedic Surgery Department)
Giza, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohammed S.K. Hamza, MD, PhD
Faculty of Medicine, Misr University for Science and Technology, Giza, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Orthopaedics surgery
Study Record Dates
First Submitted
May 17, 2026
First Posted
June 1, 2026
Study Start
September 1, 2024
Primary Completion
December 13, 2025
Study Completion
December 15, 2025
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
"There is no plan to share individual participant data (IPD) from this study outside the study team."