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Clinical Trials/NCT01437358
NCT01437358
Completed
Not Applicable

Epidural Analgesia in Intensive Care Unit Patients: an Observational Prospective Multicenter Feasibility and Safety Study

University Hospital, Clermont-Ferrand1 site in 1 country80 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
80
Locations
1
Primary Endpoint
Incidence of epidural analgesia-related complications
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
January 2012
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

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...)

Outcomes

Primary Outcomes

Incidence of epidural analgesia-related complications

Time Frame: up to 1 month

Study Sites (1)

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