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Randomized Controlled Trial
. 2023 May 31;27(1):213.
doi: 10.1186/s13054-023-04502-w.

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

Matthieu Jabaudon  1   2 , Alexandra Genevrier  3 , Samir Jaber  4   5 , Olivier Windisch  6   7   8 , Stéphanie Bulyez  8   9 , Pierre-François Laterre  10 , Etienne Escudier  11 , Achille Sossou  12 , Philippe Guerci  13   14 , Pierre-Marie Bertrand  15 , Pierre-Eric Danin  16   17 , Martin Bonnassieux  18 , Leo Bühler  6   7 , Claudia Paula Heidegger  7   8 , Russell Chabanne  3 , Thomas Godet  3 , Laurence Roszyk  19   20 , Vincent Sapin  19   20 , Emmanuel Futier  3   19 , Bruno Pereira  21 , Jean-Michel Constantin  22 ; EPIPAN study group
Collaborators, Affiliations
Randomized Controlled Trial

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

Matthieu Jabaudon et al. Crit Care. .

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.

Keywords: Acute pancreatitis; Epidural analgesia; Intensive care unit; Ventilator-free days.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT patient flowchart. * Reasons for exclusion: local infection, active central nervous system infection, history of back surgery associated with a dural space procedure, suspected, or confirmed intracranial hypertension
Fig. 2
Fig. 2
Ventilator-free days from randomization to day 30. Top: median values and interquartile ranges. Bottom: distribution of ventilator-free days when not equal to 30
Fig. 3
Fig. 3
Post-hoc subgroup analysis of the primary endpoint of ventilator-free days from randomization to day 30. The odds ratio for having 30 ventilator-free days and the incident rate ratio for the number of ventilator-free days (when not equal to 30) were computed using zero-inflated negative binomial regression
See this image and copyright information in PMC

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