WALANT Versus Local Anesthesia With Tourniquet for Carpal Tunnel Decompression (WALANT vs LA-T)
2026年5月23日 更新者: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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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-
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Cairo、埃及
- Al-Azhar University Hospital (Neurosurgery Department)
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Giza、埃及
- Misr University for Science and Technology Hospital (Orthopedic Surgery Department)
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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."
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"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."
|
|
有源比较器:Local Anesthesia With Tourniquet (LA-T)
"Patients received buffered lidocaine without epinephrine and an upper-arm pneumatic tourniquet for open carpal tunnel decompression."
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"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."
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intraoperative Pain (VAS)
大体时间:Intraoperative.
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"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."
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Intraoperative.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Infiltration Pain (VAS)
大体时间:Perioperative " During local anesthetic injection, assessed immediately after infiltration."
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"Pain at the time of local anesthetic infiltration, scored on a VAS 0-10."
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Perioperative " During local anesthetic injection, assessed immediately after infiltration."
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Tourniquet Pain (VAS) - LA-T Group Only
大体时间:Perioperative " During tourniquet inflation, assessed after the primary intraoperative pain rating."
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"Tourniquet-specific pain in the LA-T group, scored on VAS 0-10, recorded separately from overall intraoperative pain."
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Perioperative " During tourniquet inflation, assessed after the primary intraoperative pain rating."
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Operative Time
大体时间:Intraoperative (from first skin incision to final skin closure).
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"Operative time in minutes, recorded from incision to completion of skin closure."
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Intraoperative (from first skin incision to final skin closure).
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Patient Satisfaction With Operating Room Experience
大体时间:Day 1 Postoperative
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"Global patient satisfaction with the operating room experience, assessed using a numeric rating scale from 0 (not satisfied) to 10 (fully satisfied)."
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Day 1 Postoperative
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Intraoperative Complications
大体时间:Baseline up to 30 days postoperatively.
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"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."
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Baseline up to 30 days postoperatively.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Mohammed S.K. Hamza, MD, PhD、Faculty of Medicine, Misr University for Science and Technology, Giza, Egypt
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年9月1日
初级完成 (实际的)
2025年12月13日
研究完成 (实际的)
2025年12月15日
研究注册日期
首次提交
2026年5月17日
首先提交符合 QC 标准的
2026年5月23日
首次发布 (实际的)
2026年6月1日
研究记录更新
最后更新发布 (实际的)
2026年6月1日
上次提交的符合 QC 标准的更新
2026年5月23日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- WALANTvsLAT-CTD-RCT-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
"There is no plan to share individual participant data (IPD) from this study outside the study team."
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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