Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
详细描述
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
Specific Aim 1: To determine whether or not a PIFB with bupivacaine can reduce postoperative pain after cardiac surgery. This will be assessed through:
(Aim 1A) opioid consumption in the first 48 hours postoperatively (Aim 1B) patient self-reported pain scores during their hospital stay
Specific Aim 2: To estimate the effect size in order to obtain information that can be used to power future research on the use of regional modalities of analgesia for cardiac surgeries.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Interventional Bupivacaine
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
干预措施: Bupivacaine Group (Drug)
Interventional Placebo
20 cc of saline on each side of the sternum at two time points after surgery and POD1
干预措施: Placebo (Other)
结局指标
主要结局
Opioid Consumption
时间窗: 48 hours
Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
次要结局
- Pain Scores(At 6-8 hourly intervals every day until discharge or 4 days)
- ICU Length of Stay(Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days)
- Hospital Length of Stay(Measured in days admitted in the hospital, an average of 5 days)
- Number of Participants With Complications(7 days post-op on an average)
研究者
Balachundhar Subramaniam
Associate Professor of Anesthesia
Beth Israel Deaconess Medical Center