Department of Perioperative Medicine, CHU Clermont-Ferrand, 58 Rue Montalembert, 63000, Clermont-Ferrand, France.
iGReD, CNRS, INSERM, Université Clermont Auvergne, Clermont-Ferrand, France.
Crit Care. 2023 May 31;27(1):213. doi: 10.1186/s13054-023-04502-w.
Findings from preclinical studies and one pilot clinical trial suggest potential benefits of epidural analgesia in acute pancreatitis. We aimed to assess the efficacy of thoracic epidural analgesia, in addition to usual care, in improving clinical outcomes of intensive care unit patients with acute pancreatitis.
A multicenter, open-label, randomized, controlled trial including adult patients with a clinical diagnosis of acute pancreatitis upon admission to the intensive care unit. Participants were randomly assigned (1:1) to a strategy combining thoracic epidural analgesia and usual care (intervention group) or a strategy of usual care alone (control group). The primary outcome was the number of ventilator-free days from randomization until day 30.
Between June 2014 and January 2019, 148 patients were enrolled, and 135 patients were included in the intention-to-treat analysis, with 65 patients randomly assigned to the intervention group and 70 to the control group. The number of ventilator-free days did not differ significantly between the intervention and control groups (median [interquartile range], 30 days [15-30] and 30 days [18-30], respectively; median absolute difference of - 0.0 days, 95% CI - 3.3 to 3.3; p = 0.59). Epidural analgesia was significantly associated with longer duration of invasive ventilation (median [interquartile range], 14 days [5-28] versus 6 days [2-13], p = 0.02).
In a population of intensive care unit adults with acute pancreatitis and low requirement for intubation, this first multicenter randomized trial did not show the hypothesized benefit of epidural analgesia in addition to usual care. Safety of epidural analgesia in this setting requires further investigation.
ClinicalTrials.gov registration number NCT02126332 , April 30, 2014.
临床前研究和一项小型临床试验的结果表明，硬膜外镇痛在急性胰腺炎中有潜在的益处。我们旨在评估在常规治疗基础上加用胸段硬膜外镇痛是否能改善重症监护病房急性胰腺炎患者的临床结局。
这是一项多中心、开放标签、随机、对照试验，纳入了入院时即被诊断为急性胰腺炎的成年重症监护病房患者。参与者按 1:1 随机分配（随机分组）至接受胸段硬膜外镇痛联合常规治疗的策略（干预组）或接受单纯常规治疗的策略（对照组）。主要结局为从随机分组至第 30 天的无呼吸机天数。
在 2014 年 6 月至 2019 年 1 月期间，共纳入 148 例患者，135 例患者被纳入意向治疗分析，其中 65 例患者被随机分配至干预组，70 例患者被随机分配至对照组。干预组和对照组的无呼吸机天数无显著差异（中位数[四分位距]：30 天[15-30]与 30 天[18-30]；绝对差值中位数为 0.0 天，95%置信区间：-3.3 至 3.3；p=0.59）。硬膜外镇痛与更长的有创通气时间显著相关（中位数[四分位距]：14 天[5-28]与 6 天[2-13]；p=0.02）。
在急性胰腺炎且插管需求较低的重症监护病房成人中，该首次多中心随机试验未显示在常规治疗基础上加用硬膜外镇痛的预期获益。在这种情况下，硬膜外镇痛的安全性需要进一步研究。
ClinicalTrials.gov 注册号 NCT02126332，登记日期 2014 年 4 月 30 日。
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