NCT01437358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

August 30, 2011

Last Update Submit

February 27, 2012

Conditions

Critical IllnessEpidural Analgesia

Keywords

Epidural catheterEpidural analgesiaIntensive care unitSafety

Outcome Measures

Primary Outcomes (1)

  • Incidence of epidural analgesia-related complications

    up to 1 month

Study Arms (1)

intensive care unit

Other: Epidural analgesia

Interventions

Epidural analgesiaOTHER

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

intensive care unit

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • none (besides classic contra-indications for epidural analgesia catheter insertion, e.g. coagulation disorder, local infection…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 26004880DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 20, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

FR(1)