Comparisons of iv Ibuprofen and iv Paracetamol for Postoperative Pain Levels and Opioid Consumption During Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Opioid (morphine) consumption
研究概览
简要总结
The aim of this study is to evaluate and to compare the effectiveness of iv ibuprofen and iv paracetamol during bariatric surgery.
详细描述
Evaluation of effectiveness of iv ibuprofen and iv paracetamol on postoperative pain, opioid consumption, and side effects in morbidly obese patients undergoing bariatric laparoscopic surgery
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing laparoscopic sleeve gastrectomy and gastric by-pass surgery
排除标准
- •Hepatic disfunction,
- •Renal failure (creatinine > 3 mg/dL,creatinin clearance < 60 mL/dk or urine out-put < 500 mL/day ) or a history of dialysis 28 days before surgery,
- •A history of gastrointestinal bleeding or bleeding diathesis 6 weeks before surgery, therapeutic dose of anticoagulation therapy (except subcutaneous heparin prophylactic dose),
- •Angiotensin converting enzymes inhibitor or antihypertensive combination with furosemide,
- •A history of opioid addiction or opioid tolerance
- •Allergy to study drugs,
- •Noncooperative patients for pain assessments
研究组 & 干预措施
ibuprofen and morphine
iv ibuprofen 800 mg infusion at 30 min before skin incision closed and per 6 hours during postoperative period; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)
干预措施: ibuprofen (Drug)
paracetamol and morphine
iv paracetamol 1 gram infusion at 30 min before skin incision closed and per 6 hours during postoperative period; iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)
干预措施: paracetamol (Drug)
结局指标
主要结局
Opioid (morphine) consumption
时间窗: First 24 hours during postoperative period
iv morphine patient controlled analgesia for multimodal analgesia
次要结局
- Postoperative pain level(First 24 hours during postoperative period)
研究者
Gulay ERDOGAN KAYHAN
Director of the study
Inonu University