Nefopam for Post Video-Assisted Thoracoscopic Lobectomy Pain Management and the Improvement of Enhanced Recovery After Surgery (ERAS): a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- morphine consumption in first 24 hours post-operative
研究概览
简要总结
Video-assisted thoracoscopic (VATs) lobectomy is mild to moderately pain procedure. For conventional thoracotomy, there are many invasive pain control such as epidural analgesia, paravertebral block. However, for VATs, the invasive pain control somehow are too invasive. Nefopam is non-opioid painkilling medication, Serotonin, norepinephrine, dopamine reuptake inhibitor. Many study were demonstrated positive outcome of nefopam usage in many operation such as abdominal surgery, laparocopic surgery, orthopedic surgery. Nevertheless, nefopam for VATs is not well studied yet.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schedule to video-assisted thoracoscopic surgery : VATs lobectomy
- •Can operate a patient-controlled analgesia (PCA) device
- •No contraindication for nefopam
排除标准
- •Epilepsy, on monoamine oxidase (MAO) inhibitors, glaucoma
- •Creatinine clearance < 60 ml/min
- •Liver disease: child-pugh score B or C
- •Allergy to nefopam
- •Chronic opioid use
研究组 & 干预措施
Nefopam group[
干预措施: Nefopam 20 MG/ML (Drug)
placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
morphine consumption in first 24 hours post-operative
时间窗: 24 hours
morphine consumption record from patient-controlled analgesia machine in 24 hours post-operative
次要结局
- numeric pain score(24 hours)
- side effect of nefopam(24 hours)
研究者
Chaowanan Khamtuikrua
Principal Investigator
Mahidol University