Serratus Plane Block After Minimally Invasive Mitral Valve Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Difference of Numeric Rating Scale after MIC-MKR
研究概览
简要总结
Patients undergoing minimally invasive mitral valve reconstruction via small thoracotomy are randomized into two groups.
The intervention group receives serratus anterior plane block after minimally invasive mitral-valve reconstruction, following 48h infusion with ropivacaine 2% continually.
The control group receives a placebo pump without infusion. Primary endpoints are perceived pain using a numeric pain rating scale and opioid consumption during the hospital stay.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned minimal invasive mitral valve repair via right anterior thoracotomy
排除标准
- •Pregenancy
- •Opioid abuse
- •Historyof chronic pain
- •Allergy to local anaesthetics (in this case ropivacain)
- •Patients who simultaneously participate in another interventional clinical trial, unless the Principal Investigators of the clinical trials give consent by mutual agreement Soft tissue infection in the area of the procedure
研究组 & 干预措施
Continuous SAPB
postoperative serratus-anterior-plane-block 20ml Ropivacain 0,75%, pain catheter with continous administered Ropivacain (5ml/h 0,2% for 48h)
干预措施: Continous SAPB (Ropivacain) (Drug)
Continuous SAPB
postoperative serratus-anterior-plane-block 20ml Ropivacain 0,75%, pain catheter with continous administered Ropivacain (5ml/h 0,2% for 48h)
干预措施: institutional standard of care pain medication protocol (Other)
Placebo
standard of care
干预措施: institutional standard of care pain medication protocol (Other)
结局指标
主要结局
Difference of Numeric Rating Scale after MIC-MKR
时间窗: within 12, 24 and 48 hours after surgery
Numeric Rating Scale (0-10, 0=smallest value, 10=greatest value)
次要结局
- Difference of opioid consumption after MIC-MVR(within 12, 24 and 48 hours after surgery)