Randomized, Double- Blind, Controlled Trial to Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Post-operative pain: VAS
研究概览
简要总结
To evaluate the effect of wound infiltration with 0.25% Bupivacaine in laparoscopic cholecystectomy in terms of pain severity, patient satisfaction level, quality of life, hospital stay and return to job and normal activities.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
0.9% normal saline, 1.5 ml for 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy
干预措施: 0.9% normal saline (Drug)
Intervention
0.25% Bupivacaine, 1.5 ml per 1 inch incision, before closure of ports in patients undergoing Laparoscopic Cholecystectomy
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Post-operative pain: VAS
时间窗: 12 hours
Post-operative pain in visual analog scale ranging 0 to100
Post-operative pain: rating scale
时间窗: 12 HOURS
Post-operative pain in numerical rating scale ranging 0 to 4
次要结局
- Pain during hospital discharge: VAS(3-5days)
- Patient Satisfaction Level: questionnaire(24 hour)
- Hospital stay(3-5 days)
- Time taken to return to job and normal activities(15-30 days)
- Assesment of quality of life: index(15th and 30th post-operative day)
研究者
Dr. Monira Parveen
Principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh