Comparison of effectiveness of pre operative administration of oral Etoricoxib and oral Diclofenac on post operative pain relief after laparoscopic cholecystectomy-Randomized, Controlled, Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- A prospective randomized control trial to compare the efficacy of etoricoxib and diclofenac in the management of post operative pain following laparoscopic cholecystectomy
研究概览
简要总结
This study is a Double blinded prospective randomized controlled trial Comparing the effectiveness of pre operative administration of oral Etoricoxib 120mg and oral Diclofenac 100mg two hours before surgery on post operative pain relief after laparoscopic cholecystectomy and will be carried out in the Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi. The primary outcome will measures the extent of pain. The intensity of the pain variable will be recorded using a visual analog scale (VAS), ranging from 0 (no pain) to 10 (maximum pain). Each patient will be asked to rate the perceived pain at 1,2,3,4,5, 6, 8, 10,12 and 24 hour post operatively. The secondary outcomes will observe the time needed for first rescue analgesia (IV Tramadol),compare adverse effects between groups and compare total rescue analgesia dose needed between groups in post operative period .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA 1 and ASA 2 patients 2.Patient scheduled for laparoscopic cholectectomy 3.Patient between 18 to 60 yrs of age of either sex 4.Written informed consent.
排除标准
- •1.Not giving consent to study 2.ASA grade 3 and 4 3.Pregnant or breastfeeding 4.History of gastrointestinal ulcer or peptic ulcer events 5.Allergy to study drugs 6.Systemic diseases affecting kidneys, liver, blood, or central nervous system.
结局指标
主要结局
A prospective randomized control trial to compare the efficacy of etoricoxib and diclofenac in the management of post operative pain following laparoscopic cholecystectomy
时间窗: primary outcome will be the extent of pain. The intensity of the pain variable will be recorded using a visual analog scale (VAS), ranging from 0 (no pain) to 10 (maximum pain). Each patient will be asked to rate the perceived pain at 1,2,3,4,5, 6, 8, 10,12 and 24 hour post operatively
次要结局
- 1.To observe the time needed for first rescue analgesia (IV Tramadol).(2.To compare adverse effects between groups)
研究者
Dr Avnish Kumar Pandey
Institute of Medical Sciences BHU