跳至主要内容
临床试验/NCT07475884
NCT07475884已完成不适用

Effect of Fascial Plane Blocks Providing Postoperative Analgesia on Mechanical Ventilation Duration in the Intensive Care Unit and Early Oxygenation After Cardiac Surgery

Bursa City Hospital1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2025年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
206
试验地点
1
主要终点
Extubation Time

研究概览

简要总结

Cardiac surgery performed via median sternotomy is associated with significant postoperative pain due to extensive tissue trauma, sternal bone healing, and mediastinal retraction. Inadequately controlled postoperative pain represents an important source of morbidity in these patients and may adversely affect respiratory mechanics, leading to hypoventilation, atelectasis, and hypoxemia. These complications can delay extubation, prolong the duration of mechanical ventilation, and increase the length of stay in the intensive care unit (ICU). In addition, insufficient pain control may trigger sympathetic activation, resulting in increased myocardial oxygen consumption, a higher risk of arrhythmias, and impaired immune function. Traditionally, systemic opioids have been the cornerstone of postoperative pain management in cardiac surgery; however, opioid-based analgesia is associated with several adverse effects, including respiratory depression, sedation, nausea and vomiting, gastrointestinal dysfunction, and prolonged mechanical ventilation. These limitations have led to increasing interest in multimodal analgesia strategies aimed at improving postoperative pain control while reducing opioid consumption and related complications. In this context, regional analgesia techniques have emerged as important components of multimodal pain management protocols in cardiac surgery.

The aim of this study was to evaluate the effects of fascial plane blocks used as part of postoperative analgesia on postoperative pain control, opioid consumption, respiratory parameters, mechanical ventilation duration, and early oxygenation in patients undergoing open heart surgery via median sternotomy, compared with patients receiving conventional analgesic management.

详细描述

Cardiac surgery is a major surgical discipline performed on hundreds of thousands of patients worldwide and is becoming increasingly common with technological advances. Median sternotomy remains the standard surgical approach for open-heart procedures, most notably coronary artery bypass grafting (CABG) and valve reconstruction or replacement.1,2 The pain resulting from sternotomy-associated extensive tissue injury, sternal bone regeneration, and mediastinal retraction is both severe and multidimensional in nature, arising from widespread irritation of the thoracic wall, pericardium, pleura, and the involved neural structures.3 Inadequately controlled postoperative pain is a significant source of morbidity in cardiac surgery and leads to serious clinical consequences. Acute pain adversely affects respiratory mechanics, predisposing patients to hypoventilation, atelectasis, and hypoxemia; it prolongs the extubation process and increases the duration of intensive care unit (ICU) stay.4,5 Insufficient analgesia can also increase myocardial oxygen demand through sympathetic activation, heighten susceptibility to arrhythmias, and compromise immunological integrity.6 In the long term, the risk of acute pain transitioning into chronic post-sternotomy pain cannot be overlooked; this condition is known to permanently impair patients' quality of life and significantly restrict functional capacity.7 Systemic opioids have traditionally formed the cornerstone of postoperative pain management in cardiac surgery. However, opioid-based analgesia is associated with a range of adverse effects including respiratory depression, sedation, nausea and vomiting, ileus, and prolonged mechanical ventilation.8 These adverse effects are particularly consequential in the vulnerable patient population of cardiac surgery, contributing to increased clinical complexity, greater utilization of hospital resources, and potential increases in mortality.9 In this context, multimodal analgesia strategies aimed at reducing opioid consumption, limiting side effects, and accelerating postoperative recovery are gaining increasing importance.10 Regional anesthesia techniques have been rapidly integrated into cardiac surgical practice in recent years as an indispensable component of multimodal analgesia protocols. Although thoracic epidural anesthesia and paravertebral block have long been established methods with proven efficacy, their use is significantly limited by factors such as coagulopathy, systemic heparinization in cardiac surgery, and high bleeding risk.11,12 Superficial fascial plane blocks, developed alongside the widespread adoption of ultrasound technology, offer a more favorable safety profile and are attracting increasing interest in cardiac surgical applications.13 The pecto-intercostal fascial plane block (PIFB) is a relatively novel technique based on local anesthetic injection into the fascial plane between the pectoralis major muscle and the external intercostal muscles. By targeting the intercostal nerve branches of the anterior thorax and afferent fibers of the cutaneous pectoral branches, PIFB provides effective analgesia along the sternotomy incision adjacent to the sternum.14,15 The serratus anterior plane block (SAPB), on the other hand, blocks the intercostobrachial nerve and thoracic intercostal nerve branches innervating the lateral thorax through local anesthetic injection into the fascial plane between the latissimus dorsi and serratus anterior muscles and the ribs.16,17 The combination of these two blocks establishes a complementary analgesic coverage encompassing the sternotomy incision, the parasternal region, and the lateral thoracic wall.18 Both techniques possess characteristics that distinguish them in cardiac surgical patients: superficial anatomical targets, ease of ultrasound-guided application, and a safe-use profile even during anticoagulation.19 Nevertheless, studies evaluating the combined application of PIFB and SAPB in open-heart surgery remain very limited in number, and comprehensive data assessing the impact of this combination on postoperative pain control, opioid consumption, and respiratory function are still insufficient.

The aim of this study is to evaluate the effect of fascial plane block on postoperative pain scores, opioid consumption, respiratory parameters, and ICU outcomes in patients undergoing open-heart surgery via sternotomy, in comparison with patients receiving conventional analgesia.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

入选标准

  • The study included patients aged 18-80 years who underwent elective coronary artery bypass grafting (CABG) or heart valve surgery via sternotomy.

排除标准

  • were defined as follows: off-pump surgery, thoracotomy, reoperation (redo surgery), emergency surgical conditions, development of complications requiring surgical revision in the postoperative period, and incomplete perioperative data recording.

研究组 & 干预措施

Group 0 (Conventional Group)

group that does not have a block applied

干预措施: conventional analgesic regimen (Other)

Group 1 (Fascial Plane Group)

combined PIFB and SAPB group

干预措施: Fascial Plane Blocks (Other)

结局指标

主要结局

Extubation Time

时间窗: Up to 48 hours postoperatively

Time from ICU admission to tracheal extubation in hours.

Mechanical Ventilation Duration

时间窗: Up to 72 hours postoperatively

Total time on mechanical ventilator support in hours.

ICU Length of Stay

时间窗: Up to 7 days postoperatively

Duration of intensive care unit stay in hours, measured from ICU admission to discharge.

次要结局

  • PaO₂/FiO₂ Ratio(Postoperative 6th, 12th, and 24th hours)
  • Postoperative Pain Score (VAS)(Postoperative 6th, 12th, and 24th hours)
  • Total Opioid Consumption(First 24 hours postoperatively)
  • Rescue Analgesic Requirement(First 24 hours postoperatively)

研究者

发起方
Bursa City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

eralp çevikkalp

associate professor

Bursa City Hospital

研究点 (1)

Loading locations...

相似试验