To compare efficacy of transdermal Diclofenac (Nu Patch 200mg) with conventional analgesia in post operative pain management after Laparoscopic Appendicectomy - a Randomised Control Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Postoperative pain management for 1 day
研究概览
简要总结
The Randomised Control Trial is going to be conducted for comparing the efficacy of Transdermal Diclofenac patch with the conventional analgesia that is Intravenous Paracetamol in post-operative pain management of patients undergoing Laparoscopic Appendicectomy. There will be two groups- 56 Control group and 56 Test Group. In the test group, the Transdermal Patch will be applied at the back on the non hairy skin at zero hour post-operatively and the patient will be given the Visual Analog Score to evaluate pain. If VAS > 4 then rescue analgesia (Intravenous Tramadol) will be given. The other group will receive Intravenous Paracetamol. The VAS will be measured at 0, 6, 12, 18, 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing laparoscopic appendicectomy with 3 ports (two ports of 10mm at periumbilical region and Suprapubic region and one of 5mm at left iliac fossa)
- •Patients more than 18 years and equal to or less than 40 years
- •Patients with no comorbid condition
- •Patients who are willing to participate in the study.
排除标准
- •Laparoscopic converted to open procedure
- •Patients allergic to Diclofenac or any other NSAIDS
- •Difference in number and location of port sites
- •Patients less than 18 years and more than 40 years
- •Patients with comorbid conditions
- •Patients with appendicular mass/abscess/peritonitis
- •Patients with renal diseases
- •Patients with associated conditions like- pelvic abscess/collection, Meckel’s diverticulitis, pelvic inflammatory disease, any other pelvic condition.
结局指标
主要结局
Postoperative pain management for 1 day
时间窗: 1 day
次要结局
- Post Operative pain management for 2-3 days(2-3 days)
研究者
Rhythm Uppal
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi