研究动态
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为晚期妇科恶性肿瘤接受剖腹手术的患者定义最佳围手术期镇痛:一项随机对照试验。

Defining optimal perioperative analgesia in patients undergoing laparotomy for advanced gynecologic malignancy: A randomized controlled trial.

发表日期:2024 Aug 07
作者: Stuart A Ostby, Deepa Narasimhulu, Michelle A Ochs Kinney, William Cliby, Carrie Langstraat, Jamie N Bakkum-Gamez, Karen Ishitani, Maureen Lemens, Peter Martin, Bijan Borah, James Moriarty, Gretchen Glaser, Amanika Kumar, Katherine W Arendt, Sean C Dowdy
来源: GYNECOLOGIC ONCOLOGY

摘要:

加速康复外科 (ERAS) 途径利用多模式镇痛。在已经使用切开注射布比卡因脂质体 (ILB) 的途径中,我们评估了添加鞘内阿片类镇痛 (ITA) 的益处。在这项对因妇科恶性肿瘤接受剖腹手术的患者进行的随机对照非劣效性试验中,我们将患者以 1:1 的比例分配至 ILB单独使用 ITA ILB 与 150 μg 鞘内注射氢吗啡酮进行比较。主要终点是术后 24 小时的镇痛总体效益评分 (OBAS)。次要终点包括疼痛评分、静脉阿片类药物使用和护理费用。对 105 名患者的人口统计和手术因素进行了平衡。对于主要终点,单独的 ILB 并不劣于 ITA ILB(4 与 4 的 24 小时 OBAS 中位数;p = 0.70)。我们观察到,在前 24 小时内,静脉注射阿片类药物的需求(26% vs 71%;p < 0.001)和总阿片类药物需求量(中位 7.5 毫克吗啡当量 vs 39.3 毫克吗啡当量,p < 0.001)显着减少。术后 16 小时内疼痛评分出现临床相关改善,有利于 ITA ILB。指数发作的总成本、药品成本和 30 天的成本没有统计学差异。使用 OBAS 作为主要终点,单独的 ILB 不劣于 ITA ILB。然而,ITA ILB 在术后 24 小时内的重要成本中性益处包括较低的疼痛评分和减少静脉阿片类药物的需求。应考虑将 ITA 添加到已利用 ILB 的 ERAS 捆绑包中的这些早期增量好处,以优化术后即时疼痛。版权所有 © 2024 Elsevier Inc. 保留所有权利。
Enhanced recovery after surgery (ERAS) pathways utilize multimodal analgesia. In pathways already utilizing incisional injection of liposomal bupivacaine (ILB), we assessed the benefit of adding intrathecal opioid analgesia (ITA).In this randomized controlled non-inferiority trial in patients undergoing laparotomy for gynecologic malignancy, we allocated patients 1:1 to ILB alone versus ITA + ILB with 150 μg intrathecal hydromorphone. The primary endpoint was the Overall Benefit of Analgesia Score (OBAS) at 24 h following surgery. Secondary endpoints included pain scores, intravenous opioid use, and cost of care.Demographic and surgical factors were balanced for 105 patients. For the primary endpoint, ILB alone was non-inferior to ITA + ILB (median OBAS at 24 h of 4 vs 4; p = 0.70). We observed a significant reduction in the need for intravenous opioids (26% vs 71%; p < 0.001) and total opioid requirements (median 7.5 vs 39.3 mg morphine equivalents, p < 0.001) in the first 24 h. Clinically relevant improvements in pain scores were identified in the first 16 h after surgery favoring ITA + ILB. Total cost of the index episode, pharmacy costs, and costs at 30 days were not statistically different.Using OBAS as the primary endpoint, ILB alone was non-inferior to ITA + ILB. However, important cost-neutral benefits for ITA + ILB in the first 24 h post-operatively included lower pain scores and reduced need for intravenous opioids. These early, incremental benefits of adding ITA to ERAS bundles already utilizing ILB should be considered to optimize immediate post-operative pain.Copyright © 2024 Elsevier Inc. All rights reserved.