NCT02182752已完成2 期
The Effect of Tramadol on Interscalene Brachial Plexus Block With Ropivacaine in Shoulder Surgery.
Asklepieion Voulas General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative analgesia
研究概览
简要总结
The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine local anesthetic solution in interscalene brachial plexus block for shoulder surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Shoulder surgery
排除标准
- •patients on opioids
- •diabetes mellitus
- •interscalene block contraindicated
- •patient refusing regional anesthesia techniques
研究组 & 干预措施
Ropivacaine - Tramadol
Active Comparator
干预措施: Ropivacaine - Tramadol (Drug)
Ropivacaine
Active Comparator
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Postoperative analgesia
时间窗: 24 hours postoperatively
次要结局
- Persistent postoperative pain(1 month postoperatively, 3 months postoperatively)
- Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement(24 hours postoperatively)
- Evidence of sensory blockade resolution, confirmed by pin-prick test(24 hours postoperatively)
研究者
Eleftheria Soulioti
MD
Asklepieion Voulas General Hospital
研究点 (1)
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