Efficacy of Local Direct Median Nerve Block VS Brachial Plexus Block in Endoscopic Carpal Tunnel Release
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intraoperative pain measured as visual analog scale (VAS)
研究概览
简要总结
Carpal tunnel syndrome is the most common compressive neuropathy. Carpal tunnel release is indicated when failed conservative treatment. Although it can be done either with local anesthesia or brachial plexus block, there is no gold standard of anesthetic choice. The study is conducted to compare the efficacy of two methods and we hypothesized that the local direct median nerve block has effectiveness in intraoperative pain control not inferior to brachial plexus block in endoscopic carpal tunnel release.
详细描述
The study is randomized-control trial conducted in single center (Orthopaedic department, Faculty of medicine, Thammasat university) The patients with failed conservative treatment of carpal tunnel syndrome confirmed by EMG are enrolled and ramdomized with computerized block-of-4 method.The local direct median nerve block is done by the surgeon and brachial plexus block in done by single anesthesiologist after that the patient will be operated with 1-portal endoscopic carpal tunnel release (Agee technque) by single surgeon. Immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale then the pateint is asked to record the 2-hr, 4-hr ,6-hr and 12-hr postoperative pain in case record form.The patient will return the case record form at 2-week and also stitched off the wound then next follow up will be 4, 12, 24 weeks to assess functional outcome (Thai version Bonton questionaire)
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with carpal tunnel syndrome, confirmed by EMG
- •Failed conservative treatment 3 months
- •Age ≥18 years old
排除标准
- •Allergic history of xylocaine
- •Any other condition that can cause carpal tunnel syndrome or peripheral neuropathy e.g. DM, hypothyroidism, pregnancy, tumor
- •Any patient that has been coverted to open carpal tunnel release
研究组 & 干预措施
Local direct median nerve block
The local anesthetic technique is proposed by Wood SH and Logan AM in 1999 by using the plastic catheter to inject the anesthetic 4 cm proximally to the incision site direct over the median and ulna nerve
干预措施: Endoscopic carpal tunnel release under local direct median nerve block (Procedure)
Brachial plexus block
The brachial plexus block technique is axillary block performed under ultrasound-guided by the well-trained anesthesiologist.
干预措施: Endoscopic carpal tunnel release under brachial plexus block (Procedure)
结局指标
主要结局
Intraoperative pain measured as visual analog scale (VAS)
时间窗: Immediate postoperative period
Visual analog scale (VAS) from 0-10 0 means no pain 5 means moderate pain 10 means worst possible pain Immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale
次要结局
- Postoperative pain measured as visual analog scale (VAS)(2 hours, 4 hours, 6 hours and 12 hours postoperative period)
- Functional outcome of the hand measured as Thai Version Boston Questionnaire(2, 4, 12, 24 weeks postoperative period)
研究者
Kittipong Siriboonpipattana
Resident
Thammasat University