Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups
研究概览
简要总结
The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting.
详细描述
The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting. It will be compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or Female, 18-99 years old
- •All patients who will have surgery for OP-CABG
排除标准
- •Pregnant females
- •Patients with allergy to morphine
- •Patients nursing an infant
- •Patients with migraine headaches
- •Patients taking Coumadin within 7 days or demonstrating INR > 13
- •Patients taking Heparin unless documented normal partial thromboplastin time
- •Patients taking Clopidogrel in previous 7 days
- •Patients taking Ticlopidine in previous 14 days
- •Patients taking Aspirin in previous 48 hours
- •Patients receiving low molecular weight heparin therapy within 24 hours previous
- •Patients with Narcolepsy and/or sleep apnea
- •Patients on chronic opioid therapy
- •Patients participating in another study
研究组 & 干预措施
Depodur
Depodur arm
干预措施: Depodur (Drug)
Traditional
traditional management
干预措施: Depodur (Drug)
结局指标
主要结局
Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups
次要结局
未报告次要终点