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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01437358
Enrollment
80
Registered
2011-09-20
Start date
2011-08-31
Completion date
2012-01-31
Last updated
2012-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Epidural Analgesia

Keywords

Epidural catheter, Epidural analgesia, Intensive care unit, Safety

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.

Interventions

OTHEREpidural analgesia

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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…)

Design outcomes

Primary

MeasureTime frame
Incidence of epidural analgesia-related complicationsup to 1 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026