Pectoralis and Serratus Muscle Blocks for Analgesia After Minimally Invasive Cardiac Procedures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Overall Benefit Analgesia Score
研究概览
简要总结
The overall research plan is PECS/SAP blocks with liposomal bupivacaine improve the Overall Benefit Analgesia Score averaged over the postoperative days 1, 2, and 3. A 20% reduction on geometric means (i.e., true ratio of geometric means of 0.80) in OBAS will be considered the minimal clinically important benefit.
详细描述
The primary aim is to determine whether a PECS/SAP block, using a mixture of bupivacaine and liposomal bupivacaine, provides superior recovery compared to routine parenteral and enteral analgesia in patients recovering from MICS. The primary outcome will be the simple multi-dimensional quality assessment, Overall Benefit Analgesia Score (OBAS score).53 Our secondary aims are to: 1) compare cumulative postoperative opioid consumption (pain medications administered over one-day periods quantified as morphine equivalents and provided by the EMR for the day of surgery and postoperative days 1, 2, and 3; 2) evaluate respiratory mechanics (forced expiratory volume in first minute (FEV1), forced vital capacity (FVC) and peak flow) after extubation on the postoperative days 1, 2 and 3 while patients remain hospitalized; and, (3) evaluate the Quality-of-Recovery-15 score on the postoperative days 1, 2 and 3.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 years old;
- •Elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy
排除标准
- •Weight less than 50 kg;
- •Pregnancy or lactation;
- •Emergency surgery and patients transferred from the ICU to the operating room;
- •Redo cardiothoracic surgery or post-operative reoperation within 72 hours of index procedure (including minor chest wall procedures including tube thoracostomy, thoracentesis or percutaneous drain placement);
- •Anticipated endotracheal intubation > 24 hours;
- •Anticipated non-study nerve block that provides analgesia to the intercostal nerves;
- •Active systemic or cardiopulmonary infection;
- •Mechanical circulatory support;
- •Allergy or contraindication to study local anesthetics;
- •Current chronic pain or routine opioid use (patients on chronic enteral opioids like Percocet or Vicodin) in a dose of > 30 mg of morphine-milligram-equivalents for at least 10 days in last 30 days;
- •Poorly controlled psychiatric disorders;
- •Clinically important current neurologic deficit;
- •Active liver disease or cirrhosis;
- •Pacemaker generator or breast implants ipsilateral to surgery;
- •Previous participation in this study.
研究组 & 干预措施
Bupi HCl plus liposomal bupi
Pectoral fascial plane or serratus anterior plane blocks (PECSII/SAP blocks) with bupivacaine HCl plus liposomal bupivacaine.
An ultrasound guided pectoral fascial plane blocks (PECS I and II blocks) and Serratus anterior plane (SAP) block with injection of the local anesthetic.
干预措施: Exparel 266 MG Per 20 ML Injection (Drug)
Bupi HCl plus liposomal bupi
Pectoral fascial plane or serratus anterior plane blocks (PECSII/SAP blocks) with bupivacaine HCl plus liposomal bupivacaine.
An ultrasound guided pectoral fascial plane blocks (PECS I and II blocks) and Serratus anterior plane (SAP) block with injection of the local anesthetic.
干预措施: Placebo (Drug)
Control Group
Standard parenteral analgesia technique with or without incisional local anesthetic infiltration: patients randomized to control group will be given parenteral opioids (such as fentanyl or hydromorphone) until they are converted to the enteral medications such as Percocet.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Benefit Analgesia Score
时间窗: Postoperative day 1-3
Our primary outcome, Overall Benefit Analgesia Score (OBAS), was measured daily by investigators blinded to treatment on postoperative Days 1 to 3.Potential scores of the seven-item questionnaire ranged from 0 to 28 points. Higher scores means worse conditions.
次要结局
- Postoperative FEV1(Postoperatively day 1 -3)
- Cumulative Opioid Consumption Over Postoperative 3 Days(72 hours postoperative)
- Postoperative FVC(Postoperative day 1 -3)
- Postoperative Peak Flow(Postoperative day 1-3)