Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery: A Randomized, Controlled, Double-Blinded Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain with inspirometry at 24 hours after surgery
研究概览
简要总结
This is a randomized, double-blind, controlled clinical trial is to evaluate the duration of efficacy of parasternal blocks with the use of local anesthetic adjuncts for analgesia after coronary artery bypass grafting surgery.
详细描述
This study will randomize patients to either standard pain control protocols or parasternal blocks after coronary artery bypass grafting-only surgery. This study will specifically examine the effectiveness and duration of analgesia of parasternal blocks with local anesthetic adjuncts, Dexamethasone 10mg and Dexmedetomidine 50mcg, added to the local anesthetic mixture
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients coming for elective and urgent coronary artery bypass (CABG)-only surgery.
排除标准
- •Patients with a history of regular opioid use.
- •Patients with a history of chronic pain.
- •Patients unable to provide consent.
研究组 & 干预措施
Intervention group
Patients will receive bilateral parasternal blocks at the end of cardiac surgery.
干预措施: Parasternal blocks (Drug)
Control group
Patients will receive all standard care as per the hospital protocols.
干预措施: Standard of care (Drug)
结局指标
主要结局
Pain with inspirometry at 24 hours after surgery
时间窗: 24 hours after surgery
Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"
次要结局
- Inspirometry(24 hours after surgery)
- Pain score with inspirometry(12 and 48 hours after surgery)
- Patient satisfaction with pain control(at 48 hours after surgery)
- Amount of rescue analgesia administered(Total in the first 48 hours after surgery)
- Intensive Care Unit (ICU) Length of Stay(From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study)
- Hospital Length of Stay(From the date of surgery up until discharge from hospital, followed from the date of surgery up until 6 months after the completion of the study)
- Pain score at rest(12, 24 and 48 hours after surgery)
- Mobilization(From ICU arrival until first mobilization (approximately first 48 hours postoperatively))
- Opioid consumption(12, 24 and 48 hours after surgery)
- Ambulation(From ICU arrival until first ambulation (approximately first 72 hours postoperatively))
研究者
Matthew Cameron
Assistant Professor
Jewish General Hospital