Duloxetine Efficacy and Tolerability for Pain Management in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in postoperative pain between the two groups using visual analogue score (VAS)
研究概览
简要总结
Recent studies on the impact of perioperative duloxetine for treatment of acute postoperative pain have yielded positive outcomes with respect to reduction opioid consumption. The aim of the present study is to investigate the role of perioperative duloxetine on the management of postoperative pain in patients undergoing LC.
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, Outcomes Assessor)
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
- •Patients who are scheduled to undergo elective LC
排除标准
- •1- Patients with acute pancreatitis
- •Patients undergoing chronic pain treatment
- •Patients who received analgesics or sedatives 24 h before scheduled surgery
- •Patients had alcohol or drug addiction
- •Severe hepatic and renal dysfunction
- •Previous allergic response to duloxetine
- •Pregnancy and lactation
- •Patients with communication problems, cognitive dysfunction, or psychological disorders
研究组 & 干预措施
Intervention
patients scheduled for elective LC will receive 60 mg duloxetine before surgery
干预措施: Duloxetine (Drug)
Control
patients scheduled for elective LC will receive placebo before surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Change in postoperative pain between the two groups using visual analogue score (VAS)
时间窗: 24 Hours postoperative
pain will be assessed using visual analogue score (VAS) 0-100 mm (0 indicated no pain, 100 denoted the most severe pain)
次要结局
- Postoperative nausea and vomiting (PONV)(24 Hours postoperative)
研究者
Noha Mansour
Lecturer
Mansoura University