Bailey Jonathan G, Hendy Ayman, Neira Victor, Chedrawy Edgar, Uppal Vishal
Department of Anesthesia, Pain Management & Perioperative Medicine, Dalhousie University, Halifax, NS, Canada.
Department of Anesthesia, Pain Management & Perioperative Medicine, Dalhousie University, Halifax, NS, Canada.
Br J Anaesth. 2025 Apr;134(4):1161-1169. doi: 10.1016/j.bja.2024.11.042. Epub 2025 Jan 24.
Moderate-to-severe pain is common after cardiac surgery, peaking during the first and second postoperative days. Several nerve blocks for sternotomy have been described; however, the optimal location for continuous catheters has not been established. This study assessed the feasibility of a larger trial evaluating the efficacy of serratus anterior plane (SAP) catheter analgesia for sternotomy pain.
This double-blinded trial included patients undergoing cardiac surgery via sternotomy. Bilateral SAP catheters were placed in all participants, and randomised to ropivacaine or placebo. We assessed feasibility based on predetermined endpoints: (1) average recruitment rate >4 per month; (2) protocol adherence rate >90%; (3) primary outcome measurement rate >90%; and (4) significant catheter-related adverse event rate ≤2%. The quality of recovery index (QoR-15) was compared using an independent t-test.
Of 52 participants randomised, feasibility data were available for 50. A definitive study was deemed 'not feasible' in our standalone centre owing to a low recruitment rate (2.4 per month) and a high adverse event rate (pneumothorax rate 12%). There were no major protocol deviations but minor deviations in 12% of participants. Pain, opioid consumption, complications, and quality of recovery were not different between groups. Long-term pain at 3 months was low in both groups.
A single-centre trial was deemed not feasible for our setting. With limited data, the quality of recovery was not different with ropivacaine dosing of bilateral SAP catheters for sternotomy pain.
NCT04648774.
中重度疼痛在心脏手术后很常见,在术后第一和第二天达到峰值。已经描述了几种用于胸骨切开术的神经阻滞;然而,连续导管的最佳位置尚未确定。本研究评估了一项更大规模试验的可行性,该试验旨在评估前锯肌平面(SAP)导管镇痛对胸骨切开术疼痛的疗效。
这项双盲试验纳入了接受胸骨切开术心脏手术的患者。所有参与者均双侧放置SAP导管,并随机分为罗哌卡因组或安慰剂组。我们根据预定终点评估可行性:(1)平均招募率>每月4例;(2)方案依从率>90%;(3)主要结局测量率>90%;(4)与导管相关的严重不良事件发生率≤2%。使用独立t检验比较恢复质量指数(QoR-15)。
在随机分组的52名参与者中,50名有可行性数据。由于招募率低(每月2.4例)和不良事件发生率高(气胸发生率12%),在我们的独立中心进行确定性研究被认为“不可行”。没有重大方案偏差,但12%的参与者有轻微偏差。两组之间的疼痛、阿片类药物消耗量、并发症和恢复质量没有差异。两组在3个月时的长期疼痛都很低。
在我们的环境中,单中心试验被认为不可行。由于数据有限,对于胸骨切开术疼痛,双侧SAP导管使用罗哌卡因给药时恢复质量没有差异。
NCT04648774。