NCT Number: NCT07617064
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Al-Azhar University Hospital (Neurosurgery Department), Cairo, Egypt
Carpal tunnel decompression (CTD) is one of the most frequently performed hand procedures, and the optimal anesthetic technique remains debated. Traditionally, CTD has been performed under local anesthesia with a pneumatic tourniquet (LA-T), regional block, or general anesthesia; these approaches may cause tourniquet pain, require sedation, and increase resource use. Wide-awake local anesthesia no tourniquet (WALANT), using lidocaine with epinephrine infiltrated directly into the operative field, avoids the tourniquet and sedation while allowing intraoperative assessment of hand function. We conducted a multicenter, prospective, double-blinded randomized controlled trial comparing WALANT to LA-T for open CTD at two academic tertiary centers (an orthopedic surgery department in Giza and a neurosurgery department in Cairo) between December 2024 and December 2025. Adults with clinically and electrophysiologically confirmed carpal tunnel syndrome (CTS), ASA I-II, and eligible for surgical treatment were randomized 1:1 to WALANT (lidocaine with epinephrine, no tourniquet) or LA-T (lidocaine only with tourniquet). The primary outcome was overall intraoperative pain scored on a visual analog scale (VAS, 0-10). Secondary outcomes were pain during anesthetic infiltration, tourniquet pain (LA-T only), operative time, global patient satisfaction with the operating room experience, and intraoperative complications. Blinded assessors collected outcome data using standardized questionnaires immediately after surgery. A total of 100 patients were randomized (50 per group). The study adhered to the Declaration of Helsinki and CONSORT 2025 guidelines and received prior institutional ethics committee approval.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
"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."
Time frame: Intraoperative.
"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."
Time frame: Perioperative " During local anesthetic injection, assessed immediately after infiltration."
"Pain at the time of local anesthetic infiltration, scored on a VAS 0-10."
Time frame: Perioperative " During tourniquet inflation, assessed after the primary intraoperative pain rating."
"Tourniquet-specific pain in the LA-T group, scored on VAS 0-10, recorded separately from overall intraoperative pain."
Time frame: Intraoperative (from first skin incision to final skin closure).
"Operative time in minutes, recorded from incision to completion of skin closure."
Time frame: Day 1 Postoperative
"Global patient satisfaction with the operating room experience, assessed using a numeric rating scale from 0 (not satisfied) to 10 (fully satisfied)."
Time frame: Baseline up to 30 days postoperatively.
"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."
Misr University for Science and Technology
Other
Intraoperative Pain During Carpal Tunnel Release: Wide-Awake Local Anesthesia No Tourniquet Versus Local Anesthesia and Tourniquet - A Randomized Controlled Trial
Acronym: WALANT vs LA-T
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