Department of Anaesthesiology and Intensive Care Medicine, Medical University of Innsbruck, Anichstrasse 35, Innsbruck, 6020, Austria.
Department of Cardiac Surgery, Medical University of Innsbruck, Anichstrasse 35, Innsbruck, 6020, Austria.
Trials. 2023 Sep 4;24(1):570. doi: 10.1186/s13063-023-07530-7.
Classic neuraxial techniques, such as thoracic epidural anesthesia, or alternative approaches like the paravertebral block, are not indicated in cardiac surgery due to increased bleeding risk. To provide satisfactory analgesia without the need for excessive opioid use, novel ultrasound techniques gained popularity and are of growing interest. The pectoralis nerve block II (PECS II) has been shown to provide good postoperative analgesia in modified radical mastectomy and might also be suitable for minimally invasive cardiac surgery.
In a single center, prospective, triple-blinded, two-group randomized trial, 60 patients undergoing elective, unilateral minimal invasive cardiac surgery will be randomized to receive a PECS II with 30 ml of ropivacaine 0.5% (intervention group) or sodium chloride 0.9% (placebo group). The primary outcome parameter is the overall opioid demand given as intravenous morphine milligram equivalents (MME) during the first 24 h after extubation. Secondary endpoints are the visual analog scale (VAS) 2, 4, 6, 8, 12, and 24 h after extubation, the Overall Benefit of Analgesia Score (OBAS) after 24 h, the interval until extubation, and intensive care unit (ICU) discharge within 24 h, as well as the length of hospital stay (LOS).
This prospective randomized, controlled, and triple-blinded trial aims to assess if a PECS II with ropivacaine 0.5% helps to decrease the opioid demand in the first 24 h and increases postoperative pain control after minimally invasive cardiac surgery.
www.clinicaltrialsregister.eu ; EudraCT Nr: 2021-005452-11; Lukas Gasteiger MD, November 18, 2021.
经典的神经轴突技术,如胸段硬膜外麻醉,或替代方法,如椎旁阻滞,由于出血风险增加,不应用于心脏手术。为了在不使用过多阿片类药物的情况下提供令人满意的镇痛效果,新的超声技术得到了普及,并引起了越来越多的关注。胸大肌神经阻滞 II (PECS II)已被证明在改良根治性乳房切除术中有良好的术后镇痛效果,也可能适用于微创心脏手术。
在一家单中心、前瞻性、三盲、两分组随机试验中,将 60 例行择期、单侧微创心脏手术的患者随机分为接受 30ml 罗哌卡因 0.5%(干预组)或生理盐水 0.9%(安慰剂组)的 PECS II 。主要结局参数是拔管后 24 小时内静脉给予的吗啡等效剂量(MME)的总体阿片类药物需求。次要终点是拔管后 2、4、6、8、12 和 24 小时的视觉模拟评分(VAS)、拔管后 24 小时的总体镇痛效果评分(OBAS)、拔管时间和 24 小时内 ICU 出院时间,以及住院时间(LOS)。
本前瞻性随机、对照、三盲试验旨在评估罗哌卡因 0.5%的 PECS II 是否有助于减少微创心脏手术后 24 小时内的阿片类药物需求,并增加术后疼痛控制。
www.clinicaltrialsregister.eu;EudraCT Nr:2021-005452-11;Lukas Gasteiger MD,2021 年 11 月 18 日。