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WALANT Versus Local Anesthesia With Tourniquet for Carpal Tunnel Decompression (WALANT vs LA-T)

23 mei 2026 bijgewerkt door: Mohamed Ahmed Tolba Abdelsalam, Misr University for Science and Technology

Intraoperative Pain During Carpal Tunnel Release: Wide-Awake Local Anesthesia No Tourniquet Versus Local Anesthesia and Tourniquet - A Randomized Controlled Trial

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Egypte
      • Cairo, Egypte
        • Al-Azhar University Hospital (Neurosurgery Department)
      • Giza, Egypte
        • Misr University for Science and Technology Hospital (Orthopedic Surgery Department)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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."
Procedure: WALANT technique for carpal tunnel decompression
"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."
Actieve vergelijker: Local Anesthesia With Tourniquet (LA-T)
"Patients received buffered lidocaine without epinephrine and an upper-arm pneumatic tourniquet for open carpal tunnel decompression."
Procedure: Local anesthesia with tourniquet for carpal tunnel decompression
"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."

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intraoperative Pain (VAS)
Tijdsspanne: 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."
Intraoperative.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Infiltration Pain (VAS)
Tijdsspanne: Perioperative " During local anesthetic injection, assessed immediately after infiltration."
"Pain at the time of local anesthetic infiltration, scored on a VAS 0-10."
Perioperative " During local anesthetic injection, assessed immediately after infiltration."
Tourniquet Pain (VAS) - LA-T Group Only
Tijdsspanne: 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."
Perioperative " During tourniquet inflation, assessed after the primary intraoperative pain rating."
Operative Time
Tijdsspanne: Intraoperative (from first skin incision to final skin closure).
"Operative time in minutes, recorded from incision to completion of skin closure."
Intraoperative (from first skin incision to final skin closure).
Patient Satisfaction With Operating Room Experience
Tijdsspanne: 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)."
Day 1 Postoperative
Intraoperative Complications
Tijdsspanne: 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."
Baseline up to 30 days postoperatively.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Misr University for Science and Technology

Onderzoekers

  • Hoofdonderzoeker: Mohammed S.K. Hamza, MD, PhD, Faculty of Medicine, Misr University for Science and Technology, Giza, Egypt

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 september 2024

Primaire voltooiing (Werkelijk)

13 december 2025

Studie voltooiing (Werkelijk)

15 december 2025

Studieregistratiedata

Eerst ingediend

17 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

23 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • WALANTvsLAT-CTD-RCT-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

"There is no plan to share individual participant data (IPD) from this study outside the study team."

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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