Epidural Analgesia in Intensive Care Unit (APD-REA: Analgesie PeriDurale en REAnimation)
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||Epidural Analgesia in Intensive Care Unit Patients: an Observational Prospective Multicenter Feasibility and Safety Study|
- Incidence of epidural analgesia-related complications [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|intensive care unit||
Other: Epidural analgesia
The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437358
|Clermont-Ferrand, France, 63003|
|Principal Investigator:||Mathieu JABAUDON||University Hospital, Clermont-Ferrand|
|Principal Investigator:||Jean-Michel CONSTANTIN||University Hospital, Clermont-Ferrand|
|Principal Investigator:||Russel CHABANNE||University Hospital, Clermont-Ferrand|
|Principal Investigator:||Bernard CLAUD||University Hospital, Clermont-Ferrand|