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Completed

NCT Number: NCT05131633

Regional Anaesthesia in Intensive Care Unit

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH, Aix-en-Provence, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Primary outcomes

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

    Time frame: During 1 week of the study

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

Secondary outcomes

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

    Time frame: During 1 week of the study

    .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

  2. Type of RA

    Time frame: During 1 week of the study

    Nerves block or spinal anesthesia or epidural anesthesia

  3. Location of RA

    Time frame: During 1 week of the study

    ICU or step-down unit or operating room

  4. Who perform RA

    Time frame: During 1 week of the study

    Resident or senior and intensivist or anesthesiologist

  5. Name of local anesthetics used

    Time frame: During 1 week of the study

    Name of local anesthetics used

  6. Concentration of local anesthetics used

    Time frame: During 1 week of the study

    Concentration in mg/ml

  7. Indications for RA

    Time frame: During 1 week of the study

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

  8. Technical management to perform RA

    Time frame: During 1 week of the study

    Type of needle

  9. Technical management to perform RA

    Time frame: During 1 week of the study

    Use of sonography (yes / no)

  10. Technical management to perform RA

    Time frame: During 1 week of the study

    Use of electrical nerve stimulator (yes / no)

  11. Technical management to perform RA

    Time frame: During 1 week of the study

    Use of continuous catheter (yes / no)

  12. Evaluation of analgesia

    Time frame: During 1 week of the study

    Visual Analog Score for pain)

  13. Evaluation of success or not in RA

    Time frame: During 1 week of the study

    Sensitive and/or motor block

  14. Contraindication for RA

    Time frame: During 1 week of the study

    Type of contraindication

  15. Complication of RA

    Time frame: During 1 week of the study

    Type of complication

  16. Reason for removal cathete

    Time frame: During 1 week of the study

    Type of reason

  17. Duration of catheter

    Time frame: During 1 week of the study

    Duration in days

  18. ICU/stepdown units length of stay

    Time frame: Day 28 after the RA

    Length in days

  19. Hospital length of stay

    Time frame: Day 28 after the RA

    Length in days

  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

    Time frame: Day 28 after the RA

    Death or alive

  22. Ventilator-free days to day 28

    Time frame: Day 28 after the RA

    Unit : days

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Bichat Hospital
  • CH Aix
  • CH Alberville
  • CH Chambery
  • CH Martigues
  • Centre Hospitalier Universitaire de Nīmes
  • Hopital Louis Pradel
  • Hospices Civils de Lyon
  • Hôpital Edouard Herriot
  • Hôpital Saint Camille
  • Hôpital de la Timone
  • Rangueil Hospital
  • Rennes University Hospital
  • Saint Antoine University Hospital
  • University Hospital, Grenoble
  • University Hospital, Lille
  • University Hospital, Marseille
  • University Hospital, Strasbourg

Registry information

Official study title

Point-of-care Regional Anaesthesia in Intensive Care Unit. A Multicentric Professional Practice Evaluation

Acronym: Week'ALR

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2021
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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