NCT03365115Unknown不适用
Influence of Combined Intrathecal Morphine and Fentanyl in Patients Undergoing Total Knee Arthroplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 111
- 主要终点
- Postoperative pain scores at 6 hour postoperatively
研究概览
简要总结
This study is planned to investigate the efficacy of combined infusion of intrathecal morphine and fentanyl in patients undergoing total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled total knee replacement under spinal anesthesia
- •ASA I-III
排除标准
- •Coagulopathy
- •Heart disease
- •Liver disease
- •Kidney disease
- •Infection
- •Psychological disorder
- •Allergy to bupivacaine
- •Allergy to morphine
- •Allergy to fentanyl
- •Inability to use patient-controlled analgesic device
- •Opioids due to chronic pain
研究组 & 干预措施
intrathecal fentanyl
Active Comparator
干预措施: Intrathecal fentanyl (Drug)
intrathecal morphine
Active Comparator
干预措施: Intrathecal morphine (Drug)
intrathecal morphine and fentantyl
Experimental
干预措施: Intrathecal morphine (Drug)
intrathecal morphine and fentantyl
Experimental
干预措施: Intrathecal fentanyl (Drug)
结局指标
主要结局
Postoperative pain scores at 6 hour postoperatively
时间窗: At 6 hour postoperatively
Postoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain).
次要结局
- Number of participants with pruritus(At 6, 12, and 24 hour postoperatively)
- Postoperative pain scores at 12 and 24 hour postoperatively(At 12 and 24 hour postoperatively)
- Patient-controlled analgesic device requirements(At 6, 12, and 24 hour postoperatively)
- Number of participants with respiratory depression(At 6, 12, and 24 hour postoperatively)
- Number of participants with vomiting(At 6, 12, and 24 hour postoperatively)
- Number of participants with nausea(At 6, 12, and 24 hour postoperatively)
研究者
Hyun-Chang Kim
Assistant professor
Keimyung University Dongsan Medical Center
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