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CompletedNCT05131633Week'ALRUpdated Feb 17, 2023

Regional Anaesthesia in Intensive Care Unit

An observational study in Intensive Care Unit, sponsored by University Hospital, Clermont-Ferrand. Completed at 19 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-17.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Taken together, previous data indicate that regional anesthesia emerges as a new and very interesting player for pain management in ICU.

Because very few data exist about the use of RA (including PNB and neuraxial nerves blocks) by the practicians in ICU we, therefore, design this multicentric professional practice evaluation to :

  • (1) , assess the use of RA in ICU/stepdown units but initiates by anesthesiologist in the operative room
  • (2) , assess the use of RA in ICU/stepdown units directly perform by practicians in ICU
  • (3) , describe the type, modalities and indications of RA performed

This study will have no effect on the management of the ICU/stepdown units patients.

02

Conditions studied

  • Intensive Care Unit

Keywords

  • regional anesthesia
  • intensive care unit
  • analgesia
  • pain management
03

In context

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
06

What researchers measure

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.

    Time frame: During 1 week of the study

Secondary outcomes

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

    .Number of RA performed in operative room and then transferred in ICU over a week. . Prevalence of RA performed in the operative room and then transferred in ICU over a week

    Time frame: During 1 week of the study

  2. Type of RA

    Nerves block or spinal anesthesia or epidural anesthesia

    Time frame: During 1 week of the study

  3. Location of RA

    ICU or step-down unit or operating room

    Time frame: During 1 week of the study

  4. Who perform RA

    Resident or senior and intensivist or anesthesiologist

    Time frame: During 1 week of the study

  5. Name of local anesthetics used

    Name of local anesthetics used

    Time frame: During 1 week of the study

  6. Concentration of local anesthetics used

    Concentration in mg/ml

    Time frame: During 1 week of the study

  7. Indications for RA

    Analgesia or anesthesia or mobilization or nursing or weaning from mechanical ventilation

    Time frame: During 1 week of the study

  8. Technical management to perform RA

    Type of needle

    Time frame: During 1 week of the study

  9. Technical management to perform RA

    Use of sonography (yes / no)

    Time frame: During 1 week of the study

  10. Technical management to perform RA

    Use of electrical nerve stimulator (yes / no)

    Time frame: During 1 week of the study

  11. Technical management to perform RA

    Use of continuous catheter (yes / no)

    Time frame: During 1 week of the study

  12. Evaluation of analgesia

    Visual Analog Score for pain)

    Time frame: During 1 week of the study

  13. Evaluation of success or not in RA

    Sensitive and/or motor block

    Time frame: During 1 week of the study

  14. Contraindication for RA

    Type of contraindication

    Time frame: During 1 week of the study

  15. Complication of RA

    Type of complication

    Time frame: During 1 week of the study

  16. Reason for removal cathete

    Type of reason

    Time frame: During 1 week of the study

  17. Duration of catheter

    Duration in days

    Time frame: During 1 week of the study

  18. ICU/stepdown units length of stay

    Length in days

    Time frame: Day 28 after the RA

  19. Hospital length of stay

    Length in days

    Time frame: Day 28 after the RA

  20. Evaluation of vital status: on ICU/stepdown units discharge

    Time frame: Day 28 after the RA

  21. Evaluation of vital status at day 28

    Death or alive

    Time frame: Day 28 after the RA

  22. Ventilator-free days to day 28

    Unit : days

    Time frame: Day 28 after the RA

07

Study locations

19 sites
  • CH
    Aix-En-Provence, France
  • CH
    Bry-sur-Marne, France
  • CH
    Chambéry, France
  • CHU
    Clermont-Ferrand, 63000, France
  • Centre Jean-Perrin
    Clermont-Ferrand, France
  • CHU
    Grenoble, France
  • CHU
    Lille, France
  • HCL Centre des Grands Brulés
    Lyon, France
  • HCL Hôpital Sud
    Lyon, France
  • APHM la Timone
    Marseille, France
  • APHM Nord
    Marseille, France
  • CHU
    Nîmes, France
  • AHPH Saint-Antoine
    Paris, France
  • APHP Bichat
    Paris, France
  • CHU
    Reims, France
  • CHU
    Rennes, France
  • CH
    Saint-Grégoire, France
  • CHU
    Strasbourg, France
  • CHU
    Toulouse, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05131633
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Hôpital Edouard Herriot, Rangueil Hospital, Hospices Civils de Lyon, Hopital Louis Pradel, Hôpital Saint Camille, Hôpital de la Timone, University Hospital, Grenoble, University Hospital, Lille, Saint Antoine University Hospital, University Hospital, Strasbourg, University Hospital, Marseille, Centre Hospitalier Universitaire de Nīmes, CH Aix, CH Martigues, CH Alberville, CH Chambery, Rennes University Hospital, Bichat Hospital
Responsible party
Blondonnet Raïko (Dr, University Hospital, Clermont-Ferrand) — Principal investigator
First posted
Nov 23, 2021
Start date
Oct 18, 2021
Primary completion
Nov 20, 2021
Completion
Dec 31, 2021
Last update
Feb 17, 2023

Study contacts

Raïko Blondonnet
principal investigator · rblondonnet@chu-clermontferrand.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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