Clinical trial NCT01437358: Epidural Analgesia in Intensive Care Unit (APD-REA: Analgesie PeriDurale en REAnimation)
Official title: Epidural Analgesia in Intensive Care Unit Patients: an Observational Prospective Multicenter Feasibility and Safety Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Epidural Analgesia
Keywords: Epidural catheter
Epidural analgesia
Intensive care unit
Safety
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients requiring epidural analgesia, whether the epidural analgesia catheter is inserted in the ICU or outside the ICU, e.g. in the operating room

Brief summary: Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the intensive care unit settings, EA should be proposed in critically ill patients, such as postoperative or trauma patients, typically. Recent findings also support anti-inflammatory, vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA safety and feasibility in the intensive care unit settings are still lacking. The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients.

Detailed description: BACKGROUND:

Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the intensive care unit settings, EA should be proposed in critically ill patients, such as postoperative or trauma patients, typically. Recent findings also support anti-inflammatory, vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA safety and feasibility in the intensive care unit settings are still lacking.

DESIGN NARRATIVE:

This observational multicenter prospective clinical study will report the incidence of EA-related complications, such as infectious or neurologic complications, and the mean duration of EA in the ICU settings.

Patients admitted in three intensive care units (two from an University Hospital and one from a local hospital) and receiving EA will be included in the study, whether the EA catheter is inserted in the ICU or outside the ICU, e.g. in the operating room. Demographics, clinical and biological data will be recorded prospectively. The main goal is to evaluate the safety and feasibility of EA in critically ill patients, being assumed this technique is currently and routinely used in our intensive care units, in accordance with national and international guidelines on epidural analgesia practice.

Eligibility criteria: Inclusion Criteria:

* patients requiring epidural analgesia, whether the epidural analgesia catheter is inserted in the ICU or outside the ICU, e.g. in the operating room.

Exclusion Criteria:

* none (besides classic contra-indications for epidural analgesia catheter insertion, e.g. coagulation disorder, local infection...)

Primary outcomes:
measure: Incidence of epidural analgesia-related complications
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Mathieu JABAUDON
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Michel CONSTANTIN
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: Russel CHABANNE
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: Bernard CLAUD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jabaudon M, Chabanne R, Sossou A, Bertrand PM, Kauffmann S, Chartier C, Guerin R, Imhoff E, Zanre L, Brenas F, Bazin JE, Constantin JM. Epidural analgesia in the intensive care unit: An observational series of 121 patients. Anaesth Crit Care Pain Med. 2015 Aug;34(4):217-23. doi: 10.1016/j.accpm.2014.12.002. Epub 2015 May 23.