Comparison of Erector Spiane Plan Block (ESPB) Versus Pecto-intercostal Fascial Block(PIFB) for Analgesia and Respiratory Function Recovery in Cardiac Surgery: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 48hr opioid consumption
研究概览
简要总结
This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions].
The main questions it aims to answer are:
- Does ESPB provide superior analgesia than PIFB
- Do patients who receive ESPB have better recovery outcomes
详细描述
Regional nerve blocks, including Pecto-intercostal block (PIFB) and Erector spinae plane block (ESPB), can provide a certain level of analgesia for thoracic and cardiac surgeries. This study focuses on patients undergoing their first conventional sternotomy for cardiac surgery. They are randomly assigned to receive either PIFB or ESPB for pain relief. Comparisons are made between the two groups for postoperative 48-hour analgesic medication requirements, static and dynamic postoperative pain scores, improvements in postoperative respiratory function, quality of life index (QoL15), and other clinically relevant prognostic indicators.
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
- 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
- •Adults patients, elective and first-time cardiac surgery patients undergoing traditional sternotomy. Procedures include coronary artery bypass surgery, valve repair or replacement surgery, atrial and ventricular septal defect repair surgery, and other open-heart surgeries.
排除标准
- •1. Emergency surgery
- •Anticipated combined major aortic vascular surgery
- •Already admitted to the ICU or on a ventilator before surgery.
研究组 & 干预措施
Group E
Patients who receive erector spinae plane block(ESPB) before cardiac surgery
干预措施: Erector spinae plane block (ESPB) (Procedure)
Group P
Patients who receive Pecto-intercostal plane block(PIFB) before cardiac surgery
干预措施: Pecto-intercostal fascial plane blok (PIFB) (Procedure)
结局指标
主要结局
48hr opioid consumption
时间窗: Day 2
The primary outcome of this study was the total oral morphine equivalent (OME) dose received within 48 hours after surgery. OME was calculated using a conversion toolkit within our hospital's electronic medical record system, which standardizes opioid analgesic doses to oral morphine equivalents according to established guidelines
次要结局
- Postoperative static pain scores-Day 1(Day 1)
- postoperative incentive spirometry volume (ml)-Day 3(Day 3)
- Postoperative dynamic pain scores-Day 1(Day 1)
- Postoperative dynamic pain scores-Day 2(Day 2)
- postoperative incentive spirometry volume (ml)-Day 2(Day 2)
- postoperative incentive spirometry volume (ml)-Day 1(Day 1)
- Postoperative static pain scores-Day 2(Day 2)
- QoL15 (POD3)(Day 3)
- Serum cytokine (IL-6, IL-8, IL-10) - baseline(During surgery (at the time the induction phase was completed, patients were under general anesthesia, and both arterial line and central venous line were in place))
- Serum cytokine (IL-6, IL-8, IL-10)- aortic declamp(Within 10 min after the aortic declamping)
- Serum cytokine (IL-6, IL-8, IL-10)- 6hrs after aortic decalmped(6 hours after the aorta was declamped)
- Serum cytokine (IL-6, IL-8, IL-10)-24 hrs after surgery(24 hours after the surgery)
研究者
Yi-Ting Chang
Attending Anesthesiologist
Taichung Veterans General Hospital