NCT05131633

Brief Summary

Pain is a major problem in Intensive Care Unit (ICU). Adequate pain management not only means decreasing the pain intensity, but also improving the functionality and allowing the early mobilization that is a prerequisite for improving recovery and decreasing the risk of complications in ICU. The complex problems involved in pain, analgesic interventions, and outcome have been emphasized in several surveys over the past decades, but apparently with only small improvements, despite the existence of several guidelines for perioperative pain management. Regional analgesia techniques (peripheral and neuraxial nerve blocks) have the potential to decrease the physiological stress response to trauma or surgery, reducing the possibility of surgical complications and improving the outcomes. Recent studies suggested that surgical and trauma ICU patients receive opioid-hypnotics continuous infusions to prevent pain and agitation that could increase the risk of posttraumatic stress disorder and chronic neuropathic pain symptoms, and chronic opioid use. Also they may reduce the total amount of opioid analgesics necessary to achieve adequate pain control and the development of potentially dangerous side effects. The use of the regional anesthesia technique in the ICU, however, can, in part, be limited by the presence of hemodynamic instability, bleeding diathesis, and by the fear of the performing procedures potentially associated with significant side effects in heavily sedated patients. Although regional anesthesia emerges as a new and very interesting player for pain management in ICU, today very few data exists about the use of RA (including PNB and neuraxial nerves blocks) by the practicians in ICU/stepdown units. The main objective of this study is to assess the use of RA for pain management both initiates in the operative room for surgical patients then transferred in ICU/stepdown units and performs directly by the practicians in ICU/stepdown units, in several french units.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

19 active sites

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

First Submitted

Initial submission to the registry

October 3, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

October 3, 2021

Last Update Submit

February 16, 2023

Conditions

Keywords

regional anesthesiaintensive care unitanalgesiapain management

Outcome Measures

Primary Outcomes (1)

  • Our primary objective is to assess the global use of RA in ICU/stepdown units

    . Number (prevalence) of RA performed in ICU over 1 week.

    During 1 week of the study

Secondary Outcomes (22)

  • assess the use, in ICU/stepdown units patients, of RA previously initiated in the operative room by an anesthesiologist

    During 1 week of the study

  • Type of RA

    During 1 week of the study

  • Location of RA

    During 1 week of the study

  • Who perform RA

    During 1 week of the study

  • Name of local anesthetics used

    During 1 week of the study

  • +17 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All medical, surgical, and trauma patients hospitalized in the participating centers and receiving RA during the one-week study period.

You may qualify if:

  • ○ All medical, surgical, and trauma patients hospitalized in the participating centers and receiving RA during the one-week study period.

You may not qualify if:

  • Opposition to the processing of personal data
  • Age \<18 years old
  • Absolute contraindications to the perform RA
  • Previous hypersensitivity or anaphylactic reaction to local anesthetics
  • Patient under a tutelage measure or placed under judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

CH

Aix-en-Provence, France

Location

CH

Bry-sur-Marne, France

Location

CH

Chambéry, France

Location

CHU

Clermont-Ferrand, 63000, France

Location

Centre Jean-Perrin

Clermont-Ferrand, France

Location

CHU

Grenoble, France

Location

CHU

Lille, France

Location

HCL Centre des Grands Brulés

Lyon, France

Location

HCL Hôpital Sud

Lyon, France

Location

APHM la Timone

Marseille, France

Location

APHM Nord

Marseille, France

Location

CHU

Nîmes, France

Location

AHPH Saint-Antoine

Paris, France

Location

APHP Bichat

Paris, France

Location

CHU

Reims, France

Location

CHU

Rennes, France

Location

CH

Saint-Grégoire, France

Location

CHU

Strasbourg, France

Location

CHU

Toulouse, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Raïko Blondonnet

    rblondonnet@chu-clermontferrand.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 3, 2021

First Posted

November 23, 2021

Study Start

October 18, 2021

Primary Completion

November 20, 2021

Study Completion

December 31, 2021

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations