Thoracic epidural analgesia in intensive care unit patients with acute pancreatitis: the EPIPAN multicenter randomized controlled trial.
Acute pancreatitis
Epidural analgesia
Intensive care unit
Ventilator-free days
Journal
Critical care (London, England)
ISSN: 1466-609X
Titre abrégé: Crit Care
Pays: England
ID NLM: 9801902
Informations de publication
Date de publication:
31 05 2023
31 05 2023
Historique:
received:
01
04
2023
accepted:
20
05
2023
medline:
2
6
2023
pubmed:
1
6
2023
entrez:
31
5
2023
Statut:
epublish
Résumé
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.
Sections du résumé
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.
Identifiants
pubmed: 37259157
doi: 10.1186/s13054-023-04502-w
pii: 10.1186/s13054-023-04502-w
pmc: PMC10230742
doi:
Banques de données
ClinicalTrials.gov
['NCT02126332']
Types de publication
Equivalence Trial
Journal Article
Multicenter Study
Pragmatic Clinical Trial
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
213Subventions
Organisme : Société Française d'Anesthésie et de Réanimation
ID : Contrat de Recherche 2015
Organisme : Centre Hospitalier Universitaire de Clermont-Ferrand
ID : Appel d'Offres Interne 2014
Investigateurs
Elodie Caumon
(E)
Julien Amat
(J)
Dominique Morand
(D)
Renaud Guérin
(R)
Sébastien Perbet
(S)
Benjamin Rieu
(B)
Sophie Cayot
(S)
Christian Chartier
(C)
Camille Verlhac
(C)
Christine Rolhion
(C)
Justine Bourdier
(J)
Bernard Cosserant
(B)
Raiko Blondonnet
(R)
Jean-Baptiste Joffredo
(JB)
Thomas Costilles
(T)
Damien Bouvier
(D)
Lise Bernard
(L)
Jean-Etienne Bazin
(JE)
Laurence Roszyk
(L)
Lydie Marie-Anne
(L)
Raphaël Giraud
(R)
Annick Puchois
(A)
Cyril Boronad
(C)
Marine Agullo
(M)
Boris Jung
(B)
Gérald Chanques
(G)
Cécile Spirito
(C)
Marion Monnin
(M)
Albert Prades
(A)
Moussa Cisse
(M)
Anne Verchere
(A)
Claudine Gniadek
(C)
Fouad Belafia
(F)
Daniel Verzilli
(D)
Julie Carr
(J)
Audrey De Jong
(A)
Yannael Coisel
(Y)
Jean-Marc Delay
(JM)
Matthieu Conseil
(M)
Marie Gonzalez
(M)
Delphine Rosant
(D)
Michel Prevot
(M)
Bernard Claud
(B)
François Brenas
(F)
Lassane Zanre
(L)
Philippe Bray
(P)
Hélène Riera
(H)
Emilie Gadea-Deschamps
(E)
Pablo Massanet
(P)
Caroline Boutin
(C)
Saber Barbar
(S)
David-Paul De Brauwere
(DP)
Serge Lumbroso
(S)
Amélie Maurin
(A)
Sophie Lloret
(S)
Laurent Muller
(L)
Claire Roger
(C)
Jean-Yves Lefrant
(JY)
Loubna Elotmani
(L)
Audrey Ayral
(A)
Suzanne Renard
(S)
Nadège Bouskila
(N)
Gaspard Beaune
(G)
Magali Farines-Raffoul
(M)
Marie Lebouc
(M)
Auguste Dargent
(A)
Thomas Crozon
(T)
Julien Clauzel
(J)
Marinne Le Core
(M)
Thomas Rimmelé
(T)
Informations de copyright
© 2023. The Author(s).
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