Regional Anesthesia for Cardiothoracic Enhanced Recovery for Patients Undergoing Cardiac Surgery Via Sternotomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
The erector spinae plane block (ESPB) is a novel regional analgesic technique that provides pain relief with a peripheral nerve block catheter. The goal of this study is to see if bilateral ESPB catheters can improve clinical outcomes in patients undergoing cardiac surgery via sternotomy, such as decreasing the duration of postoperative mechanical ventilation, need for intravenous opioid medications, length of stay in the intensive care unit (ICU), and improving pain scores.
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
- Double (Participant, Care Provider)
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
- •Give consent to participate in study
- •planned sternotomy
- •specific procedures: CABG (coronary artery bypass grafting) or AVR (aortic valve repair or replacement) or MVR (mitral valve repair or replacement) or combination of any of 2 of these
- •Primary or first redo sternotomy
排除标准
- •Participants who cannot give consent
- •Patients who are clinically unstable or require urgent/emergent intervention
- •more than1 prior sternotomy
- •planned aortic arch procedures
- •preoperative coagulopathy (INR >1.5, PTT >35) or ongoing anticoagulation (heparin infusion, therapeutic low molecular weight heparin, warfarin, dual antiplatelet therapy)
- •Severe ventricular dysfunction (left or right ventricle)
- •Symptomatic heart failure (systolic or diastolic)
研究组 & 干预措施
Bilateral ESP catheter with Lidocaine
All participants will get the Erector Spinae Plane (ESP) catheters. Prior to transfer to the operating room, participants will receive bilateral ESP catheters at T7 level under ultrasound guidance. This arm is the treatment group and will receive lidocaine via alternating side automated infusion pump bolus dosing, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
干预措施: Bilateral ESP catheter with lidocaine (Procedure)
Bilateral ESP catheter with saline
All participants will get the Erector Spinae Plane (ESP) catheters. This arm is the control group and will have normal saline administered via ESP catheters, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
干预措施: Bilateral ESP catheter with saline (Procedure)
结局指标
主要结局
Opioid Consumption
时间窗: Duration of postoperative recovery (typically 1-2 weeks)
IV and PO opioid requirements converted to morphine equivalent
次要结局
- Length of stay in ICU(Duration of postoperative recovery (typically 1-2 weeks))
- Inflammatory biomarker analysis(First panel pre-incision; second panel 6hrs (+/-3hrs) post-procedure; third panel 24hrs (+/-3hrs) post-procedure; fourth panel 48hrs (+/-3hrs) post-procedure)
- Delirium and agitation post-operatively(Duration of ICU stay (typically 2-5 days))
- Quality of recovery at 72 hours(post-operative day 3)
- Determine post-operative pain scores(Duration of postoperative recovery (typically 1-2 weeks))
- Median time to extubation in patients with ESPB(Duration of postoperative recovery (typically 1-2 weeks))
- Length of stay in hospital(Duration of postoperative recovery (typically 1-2 weeks))
研究者
Chi-Ho Ban Tsui
Professor
Stanford University