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

23. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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."
Aktiv komparator: 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."

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraoperative Pain (VAS)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Infiltration Pain (VAS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Misr University for Science and Technology

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2024

Primær færdiggørelse (Faktiske)

13. december 2025

Studieafslutning (Faktiske)

15. december 2025

Datoer for studieregistrering

Først indsendt

17. maj 2026

Først indsendt, der opfyldte QC-kriterier

23. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • WALANTvsLAT-CTD-RCT-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

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Kliniske forsøg med Karpaltunnelsyndrom

Kliniske forsøg med WALANT technique for carpal tunnel decompression

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