Optimal Method of Pain Control After Minimally Invasive Coronary Artery Bypass Grafting
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
The purpose of this study is to compare postoperative pain control after minimally invasive coronary artery bypass grafting for patients who receive an intercostal block (an anesthetic medicine injected in an area under the ribs) in the operating room and IV acetaminophen (Tylenol) to those who receive an intercostal block and On-Q pain pump catheter (a balloon pump attached to 2 small tubes near your procedure site that automatically delivers pain medicine).
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Coronary artery disease requiring surgical intervention
- •No prior sternotomy
- •Creatinine within normal limits (0.60 - 1.10 mg/dL)
排除标准
- •Less than 18 years of age
- •Inability to provide consent or complete a written survey
- •Previous history of sternotomy
- •Contraindications to MICS-CABG or to any of the components of the 2 analgesic regimens
研究组 & 干预措施
IV acetaminophen
Patients in this group will receive intraoperative intercostal block + IV acetaminophen (1000 mg every 6 hours for adults and weight-based for any patient under 50 kg)
干预措施: IV acetaminophen (Drug)
结局指标
主要结局
Pain score
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 4 days
Pain scores will be assessed using a Numerical Rating Scale (NRS) (an 11-point scale, 0 through 10, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'). Pain scores will be entered by nursing staff every 2 hours in ICU, and every 6 hours on the floor for the duration of the hospital stay, an expected average of 4 days.
次要结局
- Medication side effects(Participants will be followed for the duration of hospital stay, an expected average of 4 days)
研究者
Kara Kallies
Academic researcher, on behalf of PI, Prem Rabindra, MD
Gundersen Lutheran Medical Foundation