NCT02247648终止2 期
Efficacy of Extended-release, Once Daily Tramadol for Post Operative in Ambulatory Shoulder Arthroscopy
Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年6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
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- quantity of hydromorphone consumed
研究概览
简要总结
The investigators hypothesize that the use of tramadol will reduce pain and analgesic consumption after arthroscopic shoulder surgery.
详细描述
The purpose of the study was to evaluate the efficacy of tramadol long acting for post operative pain in patients who had an arthroscopic shoulder surgery in ambulatory setting in comparison with a placebo. The intensity of pain was evaluated on a visual analog scale as the quantity of hydromorphone taken by patients, and the side effects during the first 72 hours.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged more than 18 year old
- •arthroscopic shoulder surgery on interscalen block
- •able to understand the protocol
- •inform consent signed
排除标准
- •chronic pain or chronic used of narcotics
- •Use of IMAO
- •Use of ISRS
- •Pulmonary chronic disease
研究组 & 干预措施
treatment
Experimental
treatment: tramadol group
干预措施: tramadol (Drug)
control
Placebo Comparator
control: placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
quantity of hydromorphone consumed
时间窗: 3 days
determination of the quantity of hydromorphone consumed at different laps
次要结局
- evaluation of pain (The intensity of pain was evaluated on a visual analog scale)(3 days)
研究者
研究点 (1)
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