Epidural Analgesia in Intensive Care Unit (APD-REA: Analgesie PeriDurale en REAnimation)

This study has been completed.
Sponsor:
Collaborators:
Faculté de Médecine Clermont-Ferrand, Université Clermont I
Pôle de Recherche et d'Enseignement Supérieur (PRES) Clermont Université
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01437358
First received: August 30, 2011
Last updated: February 27, 2012
Last verified: February 2012

August 30, 2011
February 27, 2012
August 2011
December 2011   (final data collection date for primary outcome measure)
Incidence of epidural analgesia-related complications [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01437358 on ClinicalTrials.gov Archive Site
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Epidural Analgesia in Intensive Care Unit (APD-REA: Analgesie PeriDurale en REAnimation)
Epidural Analgesia in Intensive Care Unit Patients: an Observational Prospective Multicenter Feasibility and Safety Study

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.

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.

Observational
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

  • Critical Illness
  • Epidural Analgesia
Other: Epidural analgesia
The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients
intensive care unit
Intervention: Other: Epidural analgesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
January 2012
December 2011   (final data collection date for primary outcome measure)

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…)
Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01437358
CHU-0100
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
  • Faculté de Médecine Clermont-Ferrand, Université Clermont I
  • Pôle de Recherche et d'Enseignement Supérieur (PRES) Clermont Université
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
University Hospital, Clermont-Ferrand
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP