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

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ClinicalTrials.gov Identifier: NCT01437358
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : February 28, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment
Critical Illness Epidural Analgesia Other: Epidural analgesia

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.


Study Type : Observational
Actual Enrollment : 80 participants
Time Perspective: Cross-Sectional
Official Title: Epidural Analgesia in Intensive Care Unit Patients: an Observational Prospective Multicenter Feasibility and Safety Study
Study Start Date : August 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Incidence of epidural analgesia-related complications [ Time Frame: up to 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437358


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01437358     History of Changes
Other Study ID Numbers: CHU-0100
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by University Hospital, Clermont-Ferrand:
Epidural catheter
Epidural analgesia
Intensive care unit
Safety

Additional relevant MeSH terms:
Agnosia
Critical Illness
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes