Regional Anaesthesia in Intensive Care Unit (Week'ALR)

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

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

• Study Contact: Name: Raiko Blondonnet

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During 1 week of the study
Type of RA	Nerves block or spinal anesthesia or epidural anesthesia	During 1 week of the study
Location of RA	ICU or step-down unit or operating room	During 1 week of the study
Who perform RA	Resident or senior and intensivist or anesthesiologist	During 1 week of the study
Name of local anesthetics used	Name of local anesthetics used	During 1 week of the study
Concentration of local anesthetics used	Concentration in mg/ml	During 1 week of the study
Indications for RA	Analgesia or anesthesia or mobilization or nursing or weaning from mechanical ventilation	During 1 week of the study
Technical management to perform RA	Type of needle	During 1 week of the study
Technical management to perform RA	Use of sonography (yes / no)	During 1 week of the study
Technical management to perform RA	Use of electrical nerve stimulator (yes / no)	During 1 week of the study
Technical management to perform RA	Use of continuous catheter (yes / no)	During 1 week of the study
Evaluation of analgesia	Visual Analog Score for pain)	During 1 week of the study
Evaluation of success or not in RA	Sensitive and/or motor block	During 1 week of the study
Contraindication for RA	Type of contraindication	During 1 week of the study
Complication of RA	Type of complication	During 1 week of the study
Reason for removal cathete	Type of reason	During 1 week of the study
Duration of catheter	Duration in days	During 1 week of the study
ICU/stepdown units length of stay	Length in days	Day 28 after the RA
Hospital length of stay	Length in days	Day 28 after the RA
Evaluation of vital status: on ICU/stepdown units discharge		Day 28 after the RA
Evaluation of vital status at day 28	Death or alive	Day 28 after the RA
Ventilator-free days to day 28	Unit : days	Day 28 after the RA

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Hospices Civils de Lyon; Saint Antoine University Hospital; Centre Hospitalier Universitaire de Nīmes; University Hospital, Grenoble; Rennes University Hospital; University Hospital, Lille; Hôpital Edouard Herriot; University Hospital, Marseille; University Hospital, Strasbourg; Bichat Hospital; Hôpital de la Timone; Hopital Louis Pradel; Rangueil Hospital; Hôpital Saint Camille; CH Aix; CH Martigues; CH Alberville; CH Chambery
• Investigators: Principal Investigator: Raïko Blondonnet, rblondonnet@chu-clermontferrand.fr

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): November 20, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 3, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: intensive care unit; analgesia; pain management; regional anesthesia
• Other Study ID Numbers: WEEK'ALR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No