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, Étienne Escudier, Achille Sossou, Philippe Guerci, Pierre-Marie Bertrand, Pierre-Éric Danin, Martin Bonnassieux, Léo H. Bühler, Claudia Paula Heidegger, Russell Chabanne, Thomas Godet, Laurence Roszyk, Vincent Sapin, Emmanuel Futier, Bruno Pereira, Jean‐Michel Constantin, for the EPIPAN study group, Elodie Caumon, Julien Amat, Dominique Morand, Renaud Guérin, Sébastien Perbet, Benjamin Rieu, Sophie Cayot, Christian Chartier, Camille Verlhac, Christine Rolhion, Justine Bourdier, Bernard Cosserant, Raïko Blondonnet, Jean-Baptiste Joffredo, Thomas Costilles, Damien Bouvier, Lise Bernard, Jean-Étienne Bazin, Laurence Roszyk, Lydie Marie-Anne, Raphaël Giraud, Annick Puchois, C. Boronad, Marine Agullo, Boris Jung, Gérald Chanques, C. Spirito, Marion Monnin, Albert Prades, Moussa Cissé, Anne Verchere, Claudine Gniadek, Fouad Belafia, Daniel Verzilli, Julie Carr, Audrey De Jong, Yannaël Coisel, J Delay, Matthieu Conseil, Marié González, D Rosant, Michel Prevot, Bernard Claud, François Brénas, Lassane Zanre, P Bray, H. Sánchez Riera, Emilie Gadea-Deschamps, Pablo Massanet, Caroline Boutin, Saber Davide Barbar, David-Paul De Brauwere, Serge Lumbroso, Amélie Maurin, Sophie Lloret, Laurent Müller, Claire Roger, Jean‐Yves Lefrant, Loubna Elotmani, Audrey Ayral, Suzanne Renard, Nadège Bouskila, Gaspard Beaune, Magali Farines-Raffoul, Marie Lebouc, Auguste Dargent, Thomas Crozon, Julien Clauzel, Marinne Le Core, Thomas Rimmelé
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT02126332 , April 30, 2014.