Ropivacaine Infusion to Alleviate Postoperative Pain After Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative oxycodone consumption
研究概览
简要总结
Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting (CABG) or heart valve surgery to diminish postoperative pain.
详细描述
A multiporous catheter will be introduced into sternotomy wound to CABG or heart valve surgery patients and continuous ropivacaine infusion 4 ml/h will be started immediately after surgery. Ropivacaine infusion will be administered during 48 postoperative hours. All patients receive patient controlled analgesia (PCA) oxycodone after extubation in the PACU. All patients receive a standardized anesthesia during surgery.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective CABG or heart valve surgery patients
排除标准
- •Psychic disorders
- •Sleep apnea syndrome
- •Diabetes mellitus (insulin dependent)
- •Obesity, body mass index (BMI) ≥ 35
- •Cardiac insufficiency, ejection fraction (EF) ≤ 30
研究组 & 干预措施
Ropivacaine
Ropivacaine 4 ml/h (8 mg/h) continuous infusion for 48 hours
干预措施: Ropivacaine (Drug)
Placebo
Saline infusion 4 ml/h for 48 hours
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Postoperative oxycodone consumption
时间窗: 48 postoperative hours
postoperative PCA administered oxycodone
次要结局
- Pain measured with Visual Analog Scale(48 postoperative hours)