Epidural Analgesia for Pancreatitis (Epipan Study)

NCT02126332 | Completed Phase 3

• 2 other identifiers: CHU-01882013-004652-37
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Acute pancreatitis (AP) is a common disease whose incidence in the US reaches 35 per 100,000 population annually. Its main causes in adults are gallstone migration into the common bile duct and alcohol abuse. Approximately 80% of patients with AP will develop a mild disease for which the management is mainly conservative. However 20% will develop a severe form, which is known to be associated with the development of local complications, such as pancreatic and peripancreatic necrosis, pseudocysts, and systemic complications, such as adult respiratory distress syndrome or renal failure. In the severe form of AP the mortality rate can reach 17% mainly due to multiple organ failure and pancreatic necrosis. In particular, pancreatic necrosis is associated with a death rate of up to 40%. Epidural anesthesia (EA) is widely used to induce analgesia in the perioperative period and has also been used to decrease pain in patients with AP. In addition, experimental studies have shown a specific beneficial effect of EA in AP, attributed to an anti-inflammatory effect of local anesthetics administered in the epidural space combined with a sympathetic nerve blockade, which redistributes splanchnic blood flow to non-perfused pancreatic regions. To date, EA has not been adequately tested in intensive care unit (ICU) patients with severe AP, with regards to clinical outcome. The objective of our study is therefore to test the effect of EA on lung dysfunction during severe AP, as we hypothesize that EA could limit lung failure requiring invasive mechanical ventilation (MV) or the duration of invasive MV

Conditions

Severe Acute Pancreatitis

Keywords

Severe acute pancreatitis; Epidural analgesia; Acute respiratory failure; Mechanical ventilation; Intensive Care Unit (ICU)

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days

  (defined as the number of days from day 1 to day 30 on which a patient is able to breathe without invasive assistance. A difference in ventilator-free days can reflect a difference in mortality, ventilator days among survivors, or both.)

  at day 30

Secondary Outcomes (7)

• Duration of invasive and/or non invasive mechanical ventilation

  at day 30

• incidence of various complications

  at day 30

• Biological inflammatory response

  at inclusion (day 0), on day 2 and day 7

• Cost analysis of severe AP management

  at day 30

• Incidence of the intolerance to enteral feeding

  from inclusion to day 30

Study Arms (2)

Conventional group

OTHER

2 groups: a " conventional group " in which available guidelines on analgesia are applied, and an " EA " group in which patients receive thoracic EA for at least 3 days.

Other: acetaminophen, nefopam, tramadol, opidoids

EA group (Epidural anesthesia )

EXPERIMENTAL

2 groups: a " conventional group " in which available guidelines on analgesia are applied, and an " EA " group in which patients receive thoracic EA for at least 3 days.

Other: ropivacaine and sufentanil

Interventions

ropivacaine and sufentanil OTHER

Thoracic epidural analgesia will be performed using ropivacaine (2 mg/ml), sufentanil (0.5 microg/ml) administered through a patient-controlled deviced (PCEA : patient-controlled epidural analgesia). PCEA parameters will be fixed as follows : continuous administration of 5 to 15 ml/h and bolus of 3 to 10 ml every 10 minutes. Iterative epidural administration of clonidine (1 mckg/kg) will be allowed to achieve analgesia goals.

EA group (Epidural anesthesia )

acetaminophen, nefopam, tramadol, opidoids OTHER

Conventional analgesia will include enteral and/or parental administration of usual analgesics, ranging from step 1 to step 3 drugs according to WHO classification (including acetaminophen, nefopam, tramadol, opidoids). The route, dose and frequency of analgesics administrations will be based on participating ICUs protocols.

Conventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the ICU for acute pancreatitis

You may not qualify if:

• Absolute contra-indication for thoracic epidural catheter placement (Prothrombin time \< 60%, Platelet count \< 75G/l, curative anticoagulant therapy interrupted for less than 8 hours, local infection, active central nervous system infection, history of back surgery associated with a dural space procedure, suspected or confirmed intracranial hypertension, refractory circulatory shock)
• Refractory circulatory shock despite appropriate resuscitation
• Known allergy to ropivacain, sufentanil or clonidine
• Age under 18

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

• Jabaudon M, Genevrier A, Jaber S, Windisch O, Bulyez S, Laterre PF, Escudier E, Sossou A, Guerci P, Bertrand PM, Danin PE, Bonnassieux M, Buhler L, Heidegger CP, Chabanne R, Godet T, Roszyk L, Sapin V, Futier E, Pereira B, Constantin JM; EPIPAN study group. Thoracic epidural analgesia in intensive care unit patients with acute pancreatitis: the EPIPAN multicenter randomized controlled trial. Crit Care. 2023 May 31;27(1):213. doi: 10.1186/s13054-023-04502-w.

  PMID: 37259157 DERIVED

• Bulyez S, Pereira B, Caumon E, Imhoff E, Roszyk L, Bernard L, Buhler L, Heidegger C, Jaber S, Lefrant JY, Chabanne R, Bertrand PM, Laterre PF, Guerci P, Danin PE, Escudier E, Sossou A, Morand D, Sapin V, Constantin JM, Jabaudon M; EPIPAN Study Group; AzuRea network. Epidural analgesia in critically ill patients with acute pancreatitis: the multicentre randomised controlled EPIPAN study protocol. BMJ Open. 2017 May 29;7(5):e015280. doi: 10.1136/bmjopen-2016-015280.

  PMID: 28554928 DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Ropivacaine; Sufentanil; Acetaminophen; Nefopam; Tramadol

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Oxazocines; Azocines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• Matthieu JABAUDON

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 30, 2014
• Study Start: June 6, 2014
• Primary Completion: February 26, 2019
• Study Completion: February 26, 2019
• Last Updated: May 1, 2020

Record last verified: 2014-05

Locations

FR (1)