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

Completed

• Conditions: Critical Illness; Epidural Analgesia
• Interventions: Other: Epidural analgesia

• Registration Number: NCT01437358
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-30
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-20
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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...)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intensive care unit	Epidural analgesia	-

Primary Outcome Measures

Name	Time	Method
Incidence of epidural analgesia-related complications	up to 1 month

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France