Erector Spinae Plane Block for Minimally Invasive Mitral Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total opiate consumption
研究概览
简要总结
The goal of this project is to study whether local anesthetic via the erector spinae plane (ESP) block may be beneficial in minimally invasive mitral valve surgery (MIMVS).
详细描述
This is a double blinded randomized controlled trial comparing a control group receiving cryoablation and sham block with an intervention group receiving cryoablation and ESP catheter. The primary outcome is total oral morphine equivalent (OME) consumption within the first 48 hours of recovery including intra-operative usage. Secondary outcomes to be evaluated would include pain scores, functional milestones like time to extubation, time to first PO intake, time to ambulation, time to chest tube removal, length of ICU and total hospital stay, complications, and patient satisfaction.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective mitral valve repair or replacement
- •Planned minimally invasive approach
排除标准
- •Non-English speaking
- •Emergency surgery
- •Planned or unplanned sternotomy
- •Previous history of sternotomy and cardiac surgery
- •Allergy to ropivacaine
- •Patients taking more than 60 OMEs per day
- •Patients with coagulopathy or taking anticoagulant with laboratory findings contraindicated for ESP catheter
结局指标
主要结局
Total opiate consumption
时间窗: 48 hours.
Total oral morphine equivalent (milligram) consumption within the first 48 hours of recovery including intra-operative usage, extracted from electronic medical record.
次要结局
- Length of hospital stay(Within 30 days from end of operation.)
- Pain score(48 hours)
- Time to extubation.(Within 30 days from end of operation.)
- Length of intensive care stay(Within 30 days from end of operation.)
- Time to chest tube removal(Within 30 days from end of operation.)
- Time to first oral intake(Within 30 days from end of operation.)
- Time to ambulation(Within 30 days from end of operation.)
- Patient self-reported experience with surgery and postoperative recovery(30 days after hospital discharge.)