Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of New-Onset Atrial Fibrillation (NOAF)
研究概览
简要总结
The purpose if this pilot study is to determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes.
详细描述
Patients in the intervention group will have ultrasound guided bilateral T3 paravertebral catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5% lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter during and after surgery. Patients in the control group will receive no block and undergo surgery with routine anesthetic care guided by their cardiac anesthesiologist.
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
- None
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
- •Participants must be undergoing one of the following elective or urgent (but not emergent) surgeries: A) Primary Coronary Artery Bypass Graft (CABG) B) Primary Surgical Aortic Valve Replacement (sAVR) C) Primary Surgical Mitral Valve Replacement (sMVR) D) Combined CABG & surgical valve replacement
排除标准
- •History of atrial fibrillation or flutter
- •Infective endocarditis
- •Left ventricular ejection fraction (LVEF) < 30%
- •Emergency surgery
- •Redo surgery
- •Contraindication to block placement including local anesthetic allergy, bleeding diathesis (physiologic or iatrogenic)
- •Body mass index > 35kg/m2
- •Pregnancy
研究组 & 干预措施
Experimental
Participants in this group will receive the intervention.
干预措施: Ropivacaine 0.2% Injectable Solution (Drug)
结局指标
主要结局
Incidence of New-Onset Atrial Fibrillation (NOAF)
时间窗: 5 days
The primary outcome for this trial is the incidence of new-onset atrial fibrillation (NOAF) in the first 5 days following cardiac surgery, defined as atrial fibrillation and/or flutter as recorded on a 12-lead ECG or rhythm strip for greater than 30 seconds in patients with no prior history of atrial fibrillation and/or flutter. Outcome is reported as the percent of participants with NOAF in each arm.
次要结局
- Cumulative Opioid Use - Average Dosages(24, 48, 72, 96, and 120 hours post-operatively)
- Cumulative Opioid Use - Morphine Equivalents(24, 48, 72, 96, and 120 hours post-operatively)
- Time to Extubation(approximately 5 days)
- Intensive Care Unit (ICU) Length of Stay(approximately 5 days)
- Hospital Length of Stay(approximately 7 days)
- 30-Day Mortality(30 days)
- Cumulative ICU sedation doses(24 and 72 hours post-operatively)
- Diagnosis of delirium during index hospitalization(approximately 7 days)
- Quality of Recovery 15 (QOR-15) Scores(24, 48, 72, 96, and 120 hours post-operatively)
- Average pain score(24, 48, 72, 96, and 120 hours post-operatively)
- Block-associated complications(approximately 5 days)
- Block performance time(approximately 1 hour)
- Duration of vasopressor requirement(approximately 24 hours)