Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After Video Assisted Thoracic Surgery: A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total fentanyl consumption during 24 hours
研究概览
简要总结
This prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the continuous infusion of intravenous nefopam in patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the continuous infusion of intravenous nefopam can significantly reduce postoperative opioid consumption and pain severity in patients with VATS.
详细描述
Adult patients undergoing elective unilateral VATS segmentectomy or lobectomy are randomly allocated to receive continuous nefopam infusion (n=45) or not (n=45), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA). At the end of induction, the nefopam group will receive intravenous nefopam 20mg mixed with 50ml of normal saline, and at the end of surgery this group will receive intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr. The control group will receive intravenous normal saline 50ml at the end of induction and receive intravenous normal saline 50ml at a rate of 2ml/hr.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Outcomes assessor not involved in this study will investigate the outcomes. The patient will be not informed of the infusion of nefopam by not attaching an identifiable label so that it cannot be distinguished from normal saline.
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy under general anesthesia
- •American Society of Anesthesiologists (ASA) physical classification I-II
- •Consent to IV-patient controlled analgesia use
- •Willingness and ability to sign an informed consent document
排除标准
- •Do not understand our study
- •Allergies to anesthetic or analgesic medications
- •Continuous local anesthetics infiltration for postoperative pain control
- •Patients who receive mechanical ventilation more than 2 hours after surgery
- •Pregnancy/Breast feeder
- •Medical or psychological disease that can affect the treatment response
研究组 & 干预措施
Nefopam group
At the end of induction, the nefopam group will receive intravenous nefopam 20mg mixed with 50ml of normal saline, and at the end of surgery, this group will receive intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr.
干预措施: Nefopam 80mg/day (Drug)
Control group
The control group will receive intravenous normal saline 50ml at the end of induction and receive intravenous normal saline 50ml at a rate of 2ml/hr at the end of surgery.
干预措施: Normal saline (Drug)
结局指标
主要结局
Total fentanyl consumption during 24 hours
时间窗: postoperative 24 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
次要结局
- Total fentanyl consumption(postoperative 48 hours)
- Postoperative pain score(postoperative 24, 48 hours)
- Postoperative nausea and vomiting(postoperative 24, 48 hours)
- chronic postsurgical pain(3-months after surgery)
研究者
Hojin Lee, MD
Clinical assistant professor
Seoul National University Hospital