NCT01666379已完成4 期
Pain Management After Forefoot Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Consumption of rescue opioid
研究概览
简要总结
The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol in treatment of postoperative pain after hallux valgus or hallux rigidus 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral hallux valgus or hallux rigidus surgery
- •18-75 yrs old
- •ASA I-III
排除标准
- •previous history of intolerance to the study drug
- •history of alcoholism
- •drug abuse
- •psychological or other emotional problems that are likely to invalidate informed consent
- •sleep apnoea
- •BMI ≥ 35 kg/m2
研究组 & 干预措施
Fentanyl
Experimental
干预措施: Fentanyl (Drug)
结局指标
主要结局
Consumption of rescue opioid
时间窗: on the 1st postoperative day
Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure
次要结局
- Pain on a numerical scale(on the 1st postoperative day)
研究者
Riika Merivirta
M.D.
Turku University Hospital
研究点 (1)
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