Effects of Erector Spinae Plane Block on Postoperative Systemic Functions in Patients Undergoing Open-Heart Surgery Via Sternotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity (NRS Score)
研究概览
简要总结
This prospective randomized controlled clinical trial evaluated the effects of bilateral erector spinae plane block (ESPB) on postoperative systemic functions in adult patients undergoing elective open-heart surgery via median sternotomy. Sixty-six participants were randomized to receive either bilateral ultrasound-guided ESPB before anesthesia induction or standard intravenous opioid analgesia. Postoperative outcomes-including pain scores, rescue analgesic requirements, hemodynamic parameters, respiratory variables, and laboratory values-were monitored for forty-eight hours. The study was conducted to determine whether ESPB provides improved postoperative pain control and supports systemic recovery compared with intravenous opioid-based analgesia.
详细描述
Open-heart surgery performed through median sternotomy is associated with significant postoperative pain, sympathetic activation, respiratory impairment, and delayed recovery. Conventional postoperative analgesia, primarily based on intravenous opioids, may provide adequate pain relief but is frequently limited by adverse effects such as sedation, nausea, respiratory depression, and hemodynamic fluctuations. Therefore, safer and more effective multimodal analgesia strategies are required for cardiac surgical patients.
The erector spinae plane block (ESPB) is a paraspinal interfascial block that allows the spread of local anesthetic to the dorsal and ventral rami, intercostal nerves, and paravertebral region, providing both somatic and visceral analgesia. ESPB has been increasingly used as an alternative to thoracic epidural analgesia, especially in patients undergoing cardiac surgery where neuraxial techniques may pose risks related to anticoagulation and sympathetic blockade.
This prospective randomized controlled clinical trial was designed to evaluate whether bilateral ultrasound-guided ESPB can improve postoperative systemic functions in patients undergoing elective open-heart surgery via sternotomy. A total of sixty-six adults classified as ASA II-III were randomized into two groups. The intervention group received bilateral ESPB at the T5 level using twenty milliliters of 0.25% bupivacaine per side prior to induction of general anesthesia, whereas the control group received standard intravenous opioid-based analgesia.
Postoperative outcomes were monitored for forty-eight hours and included pain scores measured by the Numeric Rating Scale (NRS), time to rescue analgesia, total analgesic consumption, hemodynamic parameters, respiratory measurements, and laboratory markers such as hemoglobin, creatinine, AST, and ALT. The primary objective was to determine whether ESPB provides superior postoperative pain control compared with intravenous opioid analgesia. Secondary objectives included assessing the effects of ESPB on hemodynamic stability, respiratory recovery, and systemic laboratory parameters.
The study was conducted after ethics committee approval, and written informed consent was obtained from all participants prior to enrollment.
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
- None
盲法说明
This study was conducted as an open-label randomized controlled trial. Neither participants nor care providers nor investigators were blinded to group allocation because the erector spinae plane block procedure is a hands-on regional anesthesia technique that cannot be feasibly masked. Outcome assessors were also not blinded due to the nature of the intervention and perioperative workflow.
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
- 是
入选标准
- •Adults aged 18 to 75 years
- •Scheduled for elective open-heart surgery via median sternotomy (CABG or valve surgery)
- •ASA physical status II-III
- •Provided written informed consent
- •BMI < 35 kg/m²
排除标准
- •Age <18 or >75 years
- •Known coagulopathy or anticoagulation contraindicating regional block
- •Infection or dermatological lesion at the injection site
- •Allergy to local anesthetics
- •Chronic use of opioids, anticonvulsants, antidepressants, or corticosteroids
- •Significant psychiatric or cognitive disorder preventing cooperation
- •Severe arrhythmia or hemodynamic instability prior to surgery
- •Local anesthetic toxicity risk factors or anatomic deformity preventing block placement
- •Non-elective or emergency cardiac surgery
研究组 & 干预措施
Erector Spinae Plane Block (ESPB)
Patients received bilateral ultrasound-guided erector spinae plane block at the T5 level before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine was injected on each side.
干预措施: Erector spinae plane block (ESPB) (Procedure)
Intravenous Opioid Analgesia (Control)
Standard intravenous opioid-based analgesia administered without regional block.
A fentanyl infusion (0.5 μg/kg/h) was initiated immediately after induction of general anesthesia and continued intraoperatively per institutional protocol.
干预措施: Intravenous Opioid Analgesia (Drug)
结局指标
主要结局
Postoperative Pain Intensity (NRS Score)
时间窗: First 12 hours after extubation (measured at 1, 6, and 12 hours)
Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at standardized postoperative time points.
次要结局
- Time to First Rescue Analgesic Requirement(Within 48 hours post-extubation)
- Total Rescue Analgesic Consumption(48 hours post-extrubation)
- Heart Rate (beats per minute)(First 24 postoperative hours)
- Mobilization Time(Up to postoperative day 3)
- Length of Hospital Stay(From completion of surgery until hospital discharge, up to 14 days.)
- Postoperative Hemoglobin Change(24 hours after surgery)
- Serum Creatinine Level (mg/dL)(Preoperative baseline and postoperative 24 hours (up to 24 hours after surgery).)
- Mean Arterial Pressure (mmHg)(First 24 postoperative hours)
- Urine Output (mL/kg/hour)(First 24 hours after surgery (up to 24 hours postoperative).)
研究者
Ali AKDOĞAN
Assistant Professor, Department of Anesthesiology and Critical Care
Karadeniz Technical University