Comparison of Patient-controlled Analgesia With Background Opioid Versus Non-opioid Infusion for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty: a Randomized, Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- postoperative pain score
研究概览
简要总结
Patients who undergoing total knee arthroplasty under spinal analgesia will be recruited and randomly assigned to the following two groups according to the regimen of PCA: (A) opioid group who receive only fentanyl citrate 1200mcg for continuous infusion drug, (B) non-opioid group who receive ketorolac tromethamine 150mg with nefopam hydrochloride 100mg for continuous infusion drug. All the patients will receive additional fentanyl citrate as bolus injection drug if they need more analgesics postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II
- •undergoing elective total knee arthroplasty under spinal anesthesia
排除标准
- •history of stomack ulceration
- •increased ICP
- •bronchial asthma
- •allergy on aspirin, NSAIDs, Nefopam
- •drug user of antiplatelet or anticoagulant
研究组 & 干预措施
opioid group
IV-PCA consisted of fentanyl
干预措施: Fentanyl (Drug)
non-opioid group
IV-PCA consisted of ketorolac and nefopam
干预措施: ketorolac tromethamine with nefopam hydrochloride (Drug)
结局指标
主要结局
postoperative pain score
时间窗: 24 hours after the surgery
evaluated by visual analogue scale
次要结局
未报告次要终点
研究者
Se-Hee Min
Assistant professor
Chung-Ang University Gwangmyeong Hospital