Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial
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
- morphine consumption
研究概览
简要总结
Abdominal surgery causes severe postoperative pain. Multi-modal pain therapy is usually applied but there is no perfect choice. It depends on physician's skill and situation. The best regimen is patient-controlled analgesia, but it requires an expensive equipment. Transdermal fentanyl patch, usually used in chronic pain relief, can steadily release fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours.
Hypothesis: If Transdermal fentanyl patch is applied 10-12 hours before surgery, it may provide good analgesia for 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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •age =>18 years
- •scheduled for abdominal surgery
排除标准
- •ASA class > 3
- •Known allergy to fentanyl or morphine
- •History of substance or alcohol abuse, and tolerance or dependence on opioids
- •Combined epidural block
- •Can't use PCA, abnormal renal / liver function
研究组 & 干预措施
Transdermal fentanyl patch
Transdermal fentanyl patch, 50 mcg/hour, was attached to the patient's chest wall at 10 pm the day before surgery
干预措施: transdermal fentanyl patch (50 mcg/hour) (Drug)
Placebo
Placebo patch was attached to the patient's chest wall at 10 pm the day before surgery
干预措施: Placebo (Drug)
结局指标
主要结局
morphine consumption
时间窗: 24 hours
Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.
次要结局
- morphine consumption(48 and 72 hours)
研究者
Thepakorn Sathitkarnmanee
Associate Professor
Khon Kaen University