Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Opioid consumption in morphine equivalents
研究概览
简要总结
Researchers hope to learn whether giving the longer-acting local anesthetic liposomal bupivacaine prior to closing the sternum is more effective in managing pain following sternotomy, than in patients who received standard bupivacaine before sternal closure. Researchers will measure this based on how much IV pain medication is used, rates on confusion, and time to remove the breathing tube.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over the age of 18 who present for elective open heart surgery that requires a sternotomy.
排除标准
- •Urgent and emergency procedures,
- •preexisting sternal infections,
- •prior sternotomy,
- •preexisting pain syndromes,
- •current chronic home opioid use,
- •anterior rib or sternal masses,
- •allergy to any of the components of liposomal bupivacaine and plain bupivacaine.
研究组 & 干预措施
Liposomal bupivacaine
Exparel (266mg) given by surgeon just prior to sternal closure
干预措施: Exparel (Drug)
Bupivacaine
40ml of 0.125% bupivacaine given by surgeon just prior to sternal closure
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Opioid consumption in morphine equivalents
时间窗: 72 hours post-surgery
Opioid consumption in morphine equivalents
次要结局
- Time to extubation in minutes will be retrieved via the electronic medical record(30 days post operative)
- Postoperative delirium as assessed by Confusion Assessment Method (CAM)-ICU(30 days post operative)
- Presence of sternal wound infection(4-6 weeks postoperative visit)
研究者
Jared Staab, DO
Study Principal Investigator
University of Kansas Medical Center