NCT06172400尚未招募不适用
Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet: a Randomized Single-blinded Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Region Skane
- 入组人数
- 120
- 主要终点
- Procedural pain
研究概览
简要总结
The goal of this clinical trial is to compare open carpal tunnel release using local anesthesia with or without a tourniquet. The main questions it aims to answer are:
- Do the tourniquet cause more procedural pain?
- Does the use of tourniquet affect the outcome after the procedure? Participants will be randomized to either local anesthesia with a tourniquet or local anesthesia with adrenaline, and undrgo standard open carpal tunnel release.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary idiopathic CTS
- •Age 18 or older
- •Symptoms of classic or probable carpal tunnel syndrome according to Katz hand diagram
- •No previous wide awake hand surgical procedures under local anesthesia
- •No planned concomitant procedures
排除标准
- •Recurrent carpal tunnel syndrome
- •Vibration induced neuropathy
- •Polyneuropathy
- •Cognitive impairment
- •Anxiety disorder
- •Swedish language insufficiency
- •Active substance abuse
- •Allergy to local anesthesia or adrenaline
- •Patient refusal to participate
研究组 & 干预措施
Touniquet
Active Comparator
Local injection of Mepivacaine (10 mg/ml) approximately 10 ml in the incisional area at least 10 minutes before surgery start. Use of a forearm tourniquet at the pressure of 250 mmHg.
干预措施: Mepivacaine, Combinations (Drug)
Adrenaline
Experimental
Local injection of Mepivacaine (10 mg/ml) and adrenaline (5 mcg/ml) approximately 10 ml in the incisional area at least 10 minutes before surgery start. Forearm tourniquet applied but not inflated.
干预措施: Mepivacaine, Combinations (Drug)
结局指标
主要结局
Procedural pain
时间窗: Day 1
Visual analog scale 0 (no pain)-100 (worst possible pain)
次要结局
- 11-item disabilities of arm, shoulder and hand questionnaire (QuickDASH)(3 months, 1 year)
- Use of diathermy/need to inflate or deflate tourniquet(Day 1)
- Atroshi-Lyrén scale(3 months, 1 year)
- Injection pain(Day 1)
- Procedure satisfaction(Day 1)
- Palmar pain scale(3 months, 1 year)
- Surgery time(Day 1)
- Adverse events(2 weeks)
研究者
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