Published May 31, 2023 | Version v1
Journal article

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

Jabaudon, Matthieu
Genevrier, Alexandra
Jaber, Samir
Windisch, Olivier
Bulyez, Stéphanie
Laterre, Pierre-François
Escudier, Etienne
Sossou, Achille
Guerci, Philippe
Bertrand, Pierre-Marie
Danin, Pierre-Eric
Bonnassieux, Martin
Bühler, Leo
Heidegger, Claudia Paula
Chabanne, Russell
Godet, Thomas
Roszyk, Laurence
Sapin, Vincent
Futier, Emmanuel
Pereira, Bruno
Constantin, Jean-Michel
Caumon, Elodie
Amat, Julien
Morand, Dominique
Guérin, Renaud
Perbet, Sébastien
Rieu, Benjamin
Cayot, Sophie
Chartier, Christian
Verlhac, Camille
Rolhion, Christine
Bourdier, Justine
Cosserant, Bernard
Blondonnet, Raiko
Joffredo, Jean-Baptiste
Costilles, Thomas
Bouvier, Damien
Bernard, Lise
Bazin, Jean-Etienne
Roszyk, Laurence
Marie-Anne, Lydie
Giraud, Raphaël
Puchois, Annick
Boronad, Cyril
Agullo, Marine
Jung, Boris
Chanques, Gérald
Spirito, Cécile
Monnin, Marion
Prades, Albert
Cisse, Moussa
Verchere, Anne
Gniadek, Claudine
Belafia, Fouad
Verzilli, Daniel
Carr, Julie
de Jong, Audrey
Coisel, Yannael
Delay, Jean-Marc
Conseil, Matthieu
Gonzalez, Marie
Rosant, Delphine
Prevot, Michel
Claud, Bernard
Brenas, François
Zanre, Lassane
Bray, Philippe
Riera, Hélène
Gadea-Deschamps, Emilie
Massanet, Pablo
Boutin, Caroline
Barbar, Saber
de Brauwere, David-Paul
Lumbroso, Serge
Maurin, Amélie
Lloret, Sophie
Muller, Laurent
Roger, Claire
Lefrant, Jean-Yves
Elotmani, Loubna
Ayral, Audrey
Renard, Suzanne
Bouskila, Nadège
Beaune, Gaspard
Farines-Raffoul, Magali
Lebouc, Marie
Dargent, Auguste
Crozon, Thomas
Clauzel, Julien
Le Core, Marinne
Rimmelé, Thomas

Description

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.

Abstract

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Additional details

Created:
October 8, 2024
Modified:
October 8, 2024