Author:
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,
Abstract
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.
Funder
Société Française d’Anesthésie et de Réanimation
Centre Hospitalier Universitaire de Clermont-Ferrand
Publisher
Springer Science and Business Media LLC
Subject
Critical Care and Intensive Care Medicine