• Crit Care · May 2023

    Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial

    Thoracic epidural analgesia in intensive care unit patients with acute pancreatitis: the EPIPAN multicenter randomized controlled trial.

    • Matthieu Jabaudon, Alexandra Genevrier, Samir Jaber, Olivier Windisch, Stéphanie Bulyez, Pierre-François Laterre, Etienne Escudier, Achille Sossou, Philippe Guerci, Pierre-Marie Bertrand, Pierre-Eric Danin, Martin Bonnassieux, Leo Bühler, Claudia Paula Heidegger, Russell Chabanne, Thomas Godet, Laurence Roszyk, Vincent Sapin, Emmanuel Futier, Bruno Pereira, Jean-Michel Constantin, and EPIPAN study group.
    • Department of Perioperative Medicine, CHU Clermont-Ferrand, 58 Rue Montalembert, 63000, Clermont-Ferrand, France. mjabaudon@chu-clermontferrand.fr.
    • Crit Care. 2023 May 31; 27 (1): 213213.

    BackgroundFindings 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.MethodsA 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.ResultsBetween 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).ConclusionsIn 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.Trial RegistrationClinicalTrials.gov registration number NCT02126332 , April 30, 2014.© 2023. The Author(s).

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