The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery (PIPACS Trial): a Prospective, Double-blind, Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Percentage Change in Forced Expiratory Volume in the First Second (FEV1)
研究概览
简要总结
In adult patients undergoing cardiac surgery, does adding an sPIP block to standard care compared to standard care alone result in a smaller decrease in PFTs?
详细描述
Postoperative pulmonary complications are a significant concern after cardiac surgery, with post-sternotomy pain contributing to impaired pulmonary function and increased risk of these complications. Parasternal intercostal plane blocks have recently emerged as a promising analgesic option for cardiac surgery, but their impact on pulmonary function tests (PFTs) has yet to be evaluated.
This prospective, single-center, double-blind, randomized controlled trial will recruit 100 adult patients undergoing elective cardiac surgery. Baseline pulmonary function, including FEV1, FVC, and PEF, will be measured preoperatively and reassessed on the first postoperative day to evaluate the primary outcome: percentage change in PFT values. Secondary outcomes include pain scores, opioid consumption, incidence of postoperative pulmonary complications during hospitalization, duration of cardiothoracic intensive care and hospital stays, and 30-day mortality.
This study aims to determine whether adding a superficial parasternal intercostal plane (sPIP) block to standard care better preserves pulmonary function in adult patients undergoing elective cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, 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 who are scheduled to undergo elective cardiac surgery via sternotomy (i.e., coronary artery bypass graft, valvular surgery, and combined surgery).
- •Body Mass Index (BMI) above 20 and below 40 kg m-2
- •Age above 18 years.
- •Eligible to sign informed consent.
排除标准
- •Emergency surgery.
- •Redo surgery.
- •Off-pump surgeries.
- •Pregnancy.
- •Preoperative mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation, ventricular assist devices).
- •Preoperative chronic pain (i.e., fibromyalgia, chronic neuropathic pain).
- •Contraindication for regional analgesia (i.e., known allergy to LA, skin lesions in the injection site).
- •Known allergy to one or more of the components of multimodal analgesia (i.e., opioids, paracetamol, tramadol, dipyrone).
- •Preexisting severe pulmonary disease (i.e., an obstructive lung disease with FEV1 below 49%, restrictive lung disease with FVC below 49%, pulmonary hypertension).
- •Criteria For Discontinuing (Postoperative Exclusion Criteria):
- •Prolonged cardiopulmonary bypass (CPB) of more than three hours.
- •Transfusion of more than three units of blood products.
- •Severe coagulation disturbance requiring prothrombin complex concentrate or recombinant factor VII.
- •Left ventricular failure with vasoactive-inotropic score (VIS) at the end of the surgery of ≥
- •Right ventricular failure requires inhaled nitric oxide.
- •Need for mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation).
- •Patients requiring mechanical ventilation for more than 24 hours postoperatively.
研究组 & 干预措施
Treatment Arm
In addition to standard care, the treatment arm will receive an ultrasound-guided bilateral single-shot superficial parasternal intercostal plane block at two levels.
干预措施: Standard care (Other)
Treatment Arm
In addition to standard care, the treatment arm will receive an ultrasound-guided bilateral single-shot superficial parasternal intercostal plane block at two levels.
干预措施: superficial parasternal intercostal plane block (Procedure)
Control Arm
The control arm will receive standard care alone.
干预措施: Standard care (Other)
结局指标
主要结局
Percentage Change in Forced Expiratory Volume in the First Second (FEV1)
时间窗: Baseline (preoperative) and first postoperative day
Percentage change in FEV1 (measured in litres) from baseline to the first postoperative day.
Percentage Change in Forced Vital Capacity (FVC)
时间窗: Baseline (preoperative) and first postoperative day
Percentage change in FVC (measured in litres) from baseline to the first postoperative day.
Percentage Change in Peak Expiratory Flow (PEF)
时间窗: Baseline (preoperative) and first postoperative day
Percentage change in PEF (measured in litres per second) from baseline to the first postoperative day.
次要结局
- Pain scores, measured by Numeric Rating Scale (NRS)(0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively)
- Opioid consumption, measured in Morphine Milligram Equivalents (MME)(0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively)
- Postoperative pulmonary complication, based on the European perioperative clinical outcome (EPCO) criteria(30 days)
- Length of stay(30 days)
- Mortality(30 days)
研究者
Shai Fein
Principal Investigator, Head of Department, Department of Anesthesia, Beilinson Hospital, Rabin Medical Centre, Petach Tikva, Israel.
Rabin Medical Center