Department of Anesthesiology, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing, China.
Trials. 2024 Jan 19;25(1):65. doi: 10.1186/s13063-024-07925-0.
Minimally invasive direct coronary artery bypass (MIDCAB) surgery offers an effective option for coronary artery disease (CAD) patients with the avoidance of median sternotomy and fast postoperative recovery. However, MIDCAB is still associated with significant postoperative pain which may lead to delayed recovery. The erector spinae plane block (ESPB) is a superficial fascial plane block. There have not been randomized controlled trials evaluating the effects of ESPB on analgesia and patient recovery following MIDCAB surgery. We therefore designed a double-blind prospective randomized placebo-controlled trial, aiming to prove the hypothesis that ESPB reduces postoperative pain scores in patients undergoing MIDCAB surgery.
The study protocol has been reviewed and approved by the Ethical Review Committee of Peking University People's Hospital. Sixty adult patients of either sex scheduled for MIDCAB surgery under general anesthesia (GA) will be included. Patients will be randomly allocated to receive either a preoperative single-shot ESPB with 30 mL of ropivacaine 0.5% (ESPB group) or normal saline 0.9% (control group). The primary outcomes are the difference between the two groups in numeric rating scale (NRS) scores at rest at different time points (6, 12, 18, 24, 48 h) after surgery. The secondary outcomes include NRS scores on deep inspiration within 48 h, postoperative hydromorphone consumption, and quality of patient recovery at 24 h and 48 h, using the Quality of Recovery-15 (QoR-15) scale. The other outcomes include intraoperative fentanyl requirements, the need for additional postoperative rescue analgesics, time to tracheal extubation and chest tube removal after surgery, incidence of postoperative nausea and vomiting (PONV) and postoperative cognitive dysfunction (POCD), intensive care unit (ICU) length of stay (LOS), hospital discharge time, and 30-day mortality. Adverse events will be also evaluated.
This is a novel randomized controlled study evaluating a preoperative ultrasound-guided single-shot unilateral ESPB on analgesia and quality of patient recovery in MIDCAB surgery. The results of this study will characterize the degree of acute postoperative pain and clinical outcomes following MIDCAB. Our study may help optimizing analgesia regimen selection and improving patient comfort in this specific population.
The study was prospectively registered with the Chinese Clinical Trial Registry (trial identifier: ChiCTR2100052810). Date of registration: November 5, 2021.
微创直接冠状动脉旁路移植术（MIDCAB）为避免正中开胸和快速术后恢复而提供了一种有效的治疗冠状动脉疾病（CAD）的选择。然而，MIDCAB 术后仍存在显著的疼痛，这可能导致术后恢复延迟。竖脊肌平面阻滞（ESPB）是一种浅表筋膜平面阻滞。目前还没有随机对照试验评估 ESPB 对 MIDCAB 术后镇痛和患者恢复的影响。因此，我们设计了一项双盲前瞻性随机安慰剂对照试验，旨在证明 ESPB 可降低接受 MIDCAB 手术的患者术后疼痛评分的假设。
本研究方案已由北京大学人民医院伦理审查委员会审查和批准。将纳入 60 名接受全身麻醉（GA）下 MIDCAB 手术的成年男女患者。患者将被随机分配接受术前单次 ESPB，用 30 mL 0.5%罗哌卡因（ESPB 组）或 0.9%生理盐水（对照组）。主要结局是两组患者术后不同时间点（6、12、18、24、48 h）静息时数字评分量表（NRS）评分的差异。次要结局包括术后 48 h 内深呼吸时的 NRS 评分、术后氢吗啡酮消耗量以及术后 24 和 48 h 时患者恢复质量，采用恢复质量 15 分（QoR-15）量表评估。其他结局包括术中芬太尼需求、术后需要额外镇痛补救、术后气管拔管和胸腔引流管拔除时间、术后恶心呕吐（PONV）和术后认知功能障碍（POCD）发生率、重症监护病房（ICU）住院时间、出院时间和 30 天死亡率。还将评估不良事件。
这是一项评估超声引导下单次单侧 ESPB 在 MIDCAB 手术中镇痛和患者恢复质量的新型随机对照研究。该研究结果将描述 MIDCAB 术后急性术后疼痛程度和临床结局。我们的研究可能有助于优化该特定人群的镇痛方案选择和提高患者舒适度。
该研究前瞻性地在中国临床试验注册中心（试验标识符：ChiCTR2100052810）注册。注册日期：2021 年 11 月 5 日。
