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临床试验/NCT07617064
NCT07617064已完成不适用

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

Misr University for Science and Technology2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ahmed Tolba Abdelsalam

Assistant Professor of Orthopaedics surgery

Misr University for Science and Technology

研究点 (2)

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