Efficacy of transdermal ketoprofen patch vs diclofenac patch in laparoscopic cholecystectomy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- To compare postoperative pain scores using Visual Analog Scale (VAS) between transdermal ketoprofen patch and diclofenac patch following laparoscopic cholecystectomy for 6 months (24 weeks).
研究概览
简要总结
After ethical approval and informed consent, adult ASA I-II patients will be scheduled for elective laparoscopic cholecyctectomy will be randomly allocated into two groups. Group K will receive a transdermal ketoprofen patch and Group D a transdermal diclofenac patch applied before the surgery. All patients will undergo standardized general anesthesia. Postoperative pain will be assessed using VAS at predetermined intervals for 24 hours. Rescue analgesia will be given as required and recorded. Data will be analyzed to compare pain scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-65 years of either gender.
- •ASA grade I and II.
- •Patients undergoing elective laparoscopic abdominal surgeries.
- •Patient willing to participate in the study.
排除标准
- •Patient refused to participate in the study Known allergy to NSAIDs Chronic pain or long term analgesic use Renal, hepatic or peptic ulcer disease Pregnancy or lactation.
结局指标
主要结局
To compare postoperative pain scores using Visual Analog Scale (VAS) between transdermal ketoprofen patch and diclofenac patch following laparoscopic cholecystectomy for 6 months (24 weeks).
时间窗: To compare postoperative pain scores using Visual Analog Scale (VAS) between transdermal ketoprofen patch and diclofenac patch following laparoscopic cholecystectomy for 6 months (24 weeks )
次要结局
- To compare the time to first rescue analgesic requirement and the total postoperative opioid/analgesic consumption within the first 24 hours(upto 24 hours)
研究者
Harshita Parihar
Peoples College of Medical Sciences and Research Centre Bhopal