A Randomized Trial Comparing Erector Spinae Plane Block Versus Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesic Efficacy in Patients Undergoing Coronary Artery Bypass Graft Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity
研究概览
简要总结
This prospective, randomized, active-controlled, double-blind, parallel-group study compares the postoperative analgesic efficacy and safety of ultrasound-guided bilateral Erector Spinae Plane Block (ESPB) versus bilateral Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in adult patients (45-85 years, ASA I-III) undergoing elective coronary artery bypass graft surgery. The primary outcome is postoperative pain intensity assessed by Numeric Rating Scale (NRS) at 2, 4, 8, 16, 24, and 48 hours after surgery. Secondary outcomes include intraoperative fentanyl/remifentanil consumption, postoperative morphine consumption, patient-controlled analgesia (PCA) demand/delivery parameters (if PCA is used), need for rescue analgesics, extubation and mobilization times, peak inspiratory flow measured by incentive spirometry at predefined time points, ICU and hospital length of stay, recovery quality (QoR-15 at 0, 24, and 48 hours), mortality, and block-related adverse events.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45-85 years
- •Scheduled for elective coronary artery bypass graft (CABG) surgery
- •American Society of Anesthesiologists (ASA) I-II-III
- •Patients who provide written informed consent and agree to participate in the study
排除标准
- •Emergency cases
- •Known allergy to local anesthetics
- •Coagulopathy (platelet count <100,000/mm³, INR >1.5, aPTT >1.5× normal)
- •Infection at the block injection site
- •Pregnancy
- •Patients who do not provide written informed consent or decline to participate after being informed
研究组 & 干预措施
Serratus Posterior Superior Intercostal Plane Block (SPSIPB)
Ultrasound-guided bilateral Serratus Posterior Superior Intercostal Plane Block will be performed preoperatively under sedation at the 2nd-3rd intercostal space. A total of 20 mL of 0.25% bupivacaine will be injected per side (total 40 mL). All participants will receive standardized general anesthesia for CABG and the same postoperative multimodal analgesia protocol.
干预措施: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) (Procedure)
Erector Spinae Plane Block (ESPB)
Ultrasound-guided bilateral Erector Spinae Plane Block will be performed preoperatively under sedation at the T4-T5 transverse process level. A total of 20 mL of 0.25% bupivacaine will be injected per side (total 40 mL). All participants will receive standardized general anesthesia for CABG and the same postoperative multimodal analgesia protocol.
干预措施: Ultrasound-guided Erector Spinae Plane Block (ESPB) (Procedure)
结局指标
主要结局
Postoperative pain intensity
时间窗: 2, 4, 8, 16, 24, and 48 hours after surgery
Pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.
次要结局
- Cumulative postoperative opioid consumption(First 24 hours after surgery)
- Need for rescue analgesia(Up to 48 hours after surgery)
- Quality of Recovery (QoR-15) score(Baseline (preoperative), postoperative 24 hours, and 48 hours after surgery)
研究者
Merve Yaman
Assistant Professor
Kutahya Health Sciences University