Additive Effect of Intravenous Acetaminophen Administered at the End of Surgery on Postoperative Pain Control With Nefopam and Fentanyl-based Patient-controlled Analgesia: A Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Total volume of administered analgesics during postoperative 24 hours
研究概览
简要总结
This study aimed to evaluate the additive effect of acetaminophen on postoperative pain control in patients receiving nefopam and fentanyl-based patient-controlled analgesia.
Participants undergoing laparoscopic hysterectomy will be randomly assigned to treatment group or control group. After end of surgery, acetaminophen or normal saline (placebo) will be administered intravenously depending on the group assigned.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing total laparoscopic hysterectomy due to uterine myoma, cervical cancer, endometriosis, uterine prolapse
排除标准
- •Liver disease (aspartate transaminase OR alanine transaminase > 80 IU/L)
- •Chronic kidney disease (GFR < 30 ml/min/1.73m2)
- •History of drug allergy
- •Chronic pain lasting more than 3 months
- •Conversion to laparotomy
- •Complex surgery (co-operation with colon surgeon or urologist)
- •Limitation in expressing pain
研究组 & 干预措施
Treatment
Patients in this group will receive 1 gram of acetaminophen intravenously after the end of surgery.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Total volume of administered analgesics during postoperative 24 hours
时间窗: 24 hours
morphine equivalent dose of patient-controlled analgesics administered during first 24 hours after end of surgery
次要结局
- Use of alternative analgesics(24 hours)
- Length of stay(From date of hospital admission until the date of discharge, an average of 1 week)
- Pain score(24 hours)
- Patient satisfaction score(24 hours)
- Postoperative nausea and vomiting(24 hours)
- Opioid-related adverse effect(24 hours)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital