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临床试验/NCT07716943
NCT07716943尚未招募不适用

Effects of Combined Anterior Serratus Plane and Pectoral-Intercostal Plane Blocks on Perioperative Analgesia and Enhanced Recovery After Surgery in Cardiopulmonary Bypass Surgery

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Postoperative pain intensity

研究概览

简要总结

Cardiopulmonary bypass surgery is associated with significant postoperative pain, which may adversely affect respiratory function, delay mobilization, prolong hospital stay, and increase postoperative complications. Within Enhanced Recovery After Surgery (ERAS) protocols, multimodal analgesia and opioid-sparing strategies have become essential components of perioperative care. Ultrasound-guided fascial plane blocks, including the anterior serratus plane block (ASPB) and pectoral-intercostal plane block (PIPB), have emerged as effective and safe regional anesthesia techniques for cardiac surgery, targeting different sensory innervation of the thoracic wall. However, evidence regarding the combined use of these two blocks remains limited. This study aimed to evaluate whether the combination of ASPB and PIPB improves intraoperative and postoperative analgesia, reduces opioid consumption, and enhances postoperative recovery and ERAS outcomes compared with standard analgesic management in patients undergoing cardiopulmonary bypass surgery.

详细描述

Cardiac surgery performed with cardiopulmonary bypass (CPB) is associated with substantial perioperative nociceptive stimulation originating from median sternotomy, chest tube placement, internal mammary artery harvesting, and extensive mediastinal tissue manipulation. Despite advances in surgical techniques and perioperative care, postoperative pain remains a major challenge following cardiac surgery. Inadequately controlled pain contributes to impaired respiratory mechanics, ineffective coughing, reduced pulmonary function, delayed mobilization, prolonged intensive care unit (ICU) and hospital stay, and an increased incidence of postoperative pulmonary complications. Furthermore, excessive perioperative opioid administration may lead to respiratory depression, postoperative nausea and vomiting, ileus, delirium, and delayed recovery, highlighting the need for effective opioid-sparing analgesic strategies.

Enhanced Recovery After Surgery (ERAS) protocols have increasingly been adopted in cardiac surgery with the aim of reducing perioperative stress, minimizing complications, and accelerating functional recovery. Contemporary ERAS guidelines emphasize multimodal analgesia as a cornerstone of perioperative management, integrating regional anesthesia techniques with non-opioid systemic analgesics to reduce opioid consumption while improving pain control. Ultrasound-guided fascial plane blocks have gained considerable popularity because they are technically straightforward, provide effective thoracic analgesia, and have a favorable safety profile compared with neuraxial techniques in anticoagulated cardiac surgical patients. Among these techniques, the anterior serratus plane block (ASPB) effectively anesthetizes the lateral thoracic wall by blocking the lateral cutaneous branches of the intercostal nerves, whereas the pectoral-intercostal plane block (PIPB) primarily targets the anterior cutaneous branches responsible for pain arising from median sternotomy. Given their complementary anatomical distributions, combining ASPB and PIPB may provide more comprehensive analgesic coverage of both the anterior and lateral thoracic walls.

Although both ASPB and PIPB have individually demonstrated promising analgesic efficacy in cardiac surgery, evidence regarding the combined use of these two fascial plane blocks remains limited. Whether the addition of ASPB to PIPB results in superior perioperative analgesia, reduced opioid requirements, improved postoperative recovery, and enhanced compliance with ERAS pathways has not yet been clearly established. Therefore, the present study aimed to compare the effects of combined anterior serratus plane block and pectoral-intercostal plane block with standard analgesic management on intraoperative opioid consumption, postoperative pain scores, postoperative analgesic requirements, recovery parameters, and ERAS-related outcomes in patients undergoing cardiopulmonary bypass surgery.

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
Single (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

入选标准

  • Patients undergoing open heart surgery via median sternotomy by the Cardiovascular Surgery Clinic
  • Patients over 18 years of age
  • ASA II-III patients

排除标准

  • - Patients undergoing emergency or recurrent surgery
  • Patients with left ventricular ejection fraction < 30
  • Patients who died per-operatively
  • Patients who do not provide informed consent
  • Presence of chronic pain
  • Presence of allergy to local anesthetics
  • Presence of infection in the area where the block will be performed
  • Coagulopathy
  • Pre-existing neurological deficit
  • Mental retardation
  • Anatomical deformity

结局指标

主要结局

Postoperative pain intensity

时间窗: At extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery.

Postoperative pain intensity will be assessed at rest and during coughing using the Visual Analog Scale at extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery. The Visual Analog Scale ranges from 0 to 10 cm, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.

次要结局

  • Intraoperative fentanyl consumption(From induction of anesthesia until the end of surgery.)
  • Postoperative tramadol consumption(During the first 24 hours after surgery.)
  • Time to extubation(From the end of surgery until extubation, assessed up to 7 days after surgery.)
  • Intensive care unit length of stay(From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 30 days after surgery.)
  • Hospital length of stay(From the date of surgery until hospital discharge, assessed up to 30 days after surgery.)
  • Incidence of postoperative cardiac arrhythmias(From the end of surgery until hospital discharge, assessed up to 30 days after surgery.)
  • Incidence of block-related complications(From block administration until hospital discharge, assessed up to 30 days after surgery.)
  • Incidence of postoperative surgical complications(From the end of surgery until hospital discharge, assessed up to 30 days after surgery.)
  • Time to thoracic drain removal(From the end of surgery until removal of all thoracic drains, assessed up to 30 days after surgery.)
  • Time to urinary catheter removal(From the end of surgery until urinary catheter removal, assessed up to 30 days after surgery.)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leyla Kılınc

associate professor

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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