NCT07617064

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

May 17, 2026

Last Update Submit

May 23, 2026

Conditions

Keywords

Carpal tunnel releaseWide-awake local anesthesia no tourniquetWALANTLocal anesthesia with tourniquetHand surgeryIntraoperative painPatient satisfaction

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."

Procedure: WALANT technique for 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."

Procedure: Local anesthesia with tourniquet for 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."

WALANT (Wide-Awake Local Anesthesia No Tourniquet)

"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."

Local Anesthesia With Tourniquet (LA-T)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Misr University for Science and Technology Hospital (Orthopedic Surgery Department)

Giza, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromePatient Satisfaction

Interventions

Anesthesia, LocalTourniquets

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaEquipment and Supplies

Study Officials

  • Mohammed S.K. Hamza, MD, PhD

    Faculty of Medicine, Misr University for Science and Technology, Giza, Egypt

    PRINCIPAL INVESTIGATOR

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."

Locations