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

NCT ID: NCT01437358

Last Updated: 2012-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Critical Illness Epidural Analgesia

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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intensive care unit

Epidural analgesia

Intervention Type OTHER

The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients

Interventions

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Epidural analgesia

The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients

Intervention Type OTHER

Eligibility Criteria

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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…)
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu JABAUDON

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Jean-Michel CONSTANTIN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Russel CHABANNE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Bernard CLAUD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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Jabaudon M, Chabanne R, Sossou A, Bertrand PM, Kauffmann S, Chartier C, Guerin R, Imhoff E, Zanre L, Brenas F, Bazin JE, Constantin JM. Epidural analgesia in the intensive care unit: An observational series of 121 patients. Anaesth Crit Care Pain Med. 2015 Aug;34(4):217-23. doi: 10.1016/j.accpm.2014.12.002. Epub 2015 May 23.

Reference Type DERIVED
PMID: 26004880 (View on PubMed)

Other Identifiers

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CHU-0100

Identifier Type: -

Identifier Source: org_study_id

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