Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours
研究概览
简要总结
Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbidly Obese and body mass index (BMI) of 35
- •Between ages 20-17
- •Candidates for Laparoscopic Bariatric Surgery
排除标准
- •know hypersensitivity to acetaminophen or opioids
- •impairment in liver function
- •renal dysfunction
- •mental retardation
研究组 & 干预措施
Arm 1 - Active Drug
Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
干预措施: Acetaminophen (Drug)
Arm 2 - Placebo
Preoperative IV Placebo (0.9 Sodium Chloride 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours
时间窗: baseline and 24 hours
The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)
次要结局
- Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours(baseline and 24 hours)
- Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent.(24 hours after baseline)