Comparison of the Postoperative Analgesia Effectiveness of Preemptive Intravenous Ibuprofen and Paracetamol in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Morphine consumption
研究概览
简要总结
This study will evaluate two different analgesic regimen used for acute postoperative pain.
详细描述
Laparoscopic cholecystectomy is a type of surgery that causes moderate postoperative pain. Paracetamol and non-steroid anti-inflammatory analgesics plus opioids are the mainstay treatment options of the moderate postoperative pain. These drugs are the most common used analgesics to ameliorate this type of pain and to reduce the consumption of opioids and their side effects.
Ibuprofen is a well-known anti-inflammatory drug and has been used as an oral formula for a long time. Few studies using its new intravenous formula had been conducted to evaluate its effectiveness for mixed type of surgeries . However, its intravenous formula has not been studied for laparoscopic cholecystectomy. Therefore, this study will compare the effects of postoperative analgesic potencies of preemptive intravenous paracetamol and ibuprofen in patients undergoing laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist Functional Status 1-2
- •Body mass index smaller than 30
- •Undergoing laparoscopic cholecystectomy
- •Age between 18-60 years
排除标准
- •Age under 18, above 60
- •Weight under 40 kg
- •Body mass index above 30
- •Contraindication for opioid and non-steroid anti-inflammatory drug usage
- •Allergy against paracetamol, opioids and anti-inflammatory drugs
- •Peptic ulcer
- •Tendency to bleeding
- •Pregnancy or breast feeding
- •Moderate or severe renal, hepatic or cardiac insufficiency
- •Coronary artery disease
研究组 & 干预措施
Paracetamol
Paracetamol (Paracerol) 1 gram will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.
干预措施: Paracetamol (Drug)
Ibuprofen
Ibuprofen (Intrafen) 800 mg will be administered intravenously. The first dose will be infused for 10 minutes after the induction of anesthesia and before the first surgical incision. The remaining three doses will be administered every 6 hours for postoperative 24 hours.
干预措施: Ibuprofen 800 mg (Drug)
结局指标
主要结局
Morphine consumption
时间窗: The first 24 hours after the completion of the surgery
Total morphine consumption during the 24 hours of early postoperative period
次要结局
- VAS scores(The first 24 hours after the completion of the surgery)
- Morphine side effects(The first 24 hours after the completion of the surgery)