Opioid-sparing Effect of Intravenous Ibuprofen
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 主要终点
- Morphine Consumption
研究概览
简要总结
The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in patients undergoing percutaneous nephrolithotomy (PCNL).
详细描述
Eighty patients who will undergoing PCNL are randomized to intravenous paracetamol (n=40) and intravenous ibuprofen (n=40) groups. Patients will receive 100 mL of physiologic saline with 1 g IV paracetamol or 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL in the paracetamol and ibuprofen groups, respectively. Patients in both groups will receive intravenous tramadol with patient controlled analgesia device (PCA).
The visual analog scale (VAS) will used to evaluate pain intensity scores in the postoperative period.
Total tramadol consumption, mean VAS score in the 1, 8 and 24 hours, demographic variables, operative variables, and side effects will record.
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, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Study include 80 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-70 years who scheduled for percutaneous nephrolithotomy operation.
排除标准
- •chronic pain,
- •psychiatric disease,
- •renal dysfunction,
- •allergy to nonsteroidal anti-inflammatory drugs,
- •history of drug addiction,
- •pregnancy,
- •inability to use a patient controlled analgesia (PCA) device.
研究组 & 干预措施
Paracetamol
Patients will receive 100 mL of physiologic saline with 1 g IV acetaminophen (paracetamol) 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.
干预措施: Acetaminophen (Drug)
ibuprofen
Patients will receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Morphine Consumption
时间窗: postoperatively 24 hours
次要结局
- Visual Analog Scale(postoperatively 30 minute, 2, 4, 6,12 and 24 hours)
研究者
Muharrem Ucar
Principal Investigator
Inonu University