Clinical trial NCT05131633: Regional Anaesthesia in Intensive Care Unit
Official title: Point-of-care Regional Anaesthesia in Intensive Care Unit. A Multicentric Professional Practice Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit
Keywords: regional anesthesia
intensive care unit
analgesia
pain management
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Hôpital Edouard Herriot
name: Rangueil Hospital
name: Hospices Civils de Lyon
name: Hopital Louis Pradel
name: Hôpital Saint Camille
name: Hôpital de la Timone
name: University Hospital, Grenoble
name: University Hospital, Lille
name: Saint Antoine University Hospital
name: University Hospital, Strasbourg
name: University Hospital, Marseille
name: Centre Hospitalier Universitaire de Nīmes
name: CH Aix
name: CH Martigues
name: CH Alberville
name: CH Chambery
name: Rennes University Hospital
name: Bichat Hospital
First posted: 2021-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Our primary objective is to assess the global use of RA in ICU/stepdown units
timeFrame: During 1 week of the study
Secondary outcomes:
measure: assess the use, in ICU/stepdown units patients, of RA previously initiated in the operative room by an anesthesiologist
timeFrame: During 1 week of the study
measure: Type of RA
timeFrame: During 1 week of the study
measure: Location of RA
timeFrame: During 1 week of the study
measure: Who perform RA
timeFrame: During 1 week of the study
measure: Name of local anesthetics used
timeFrame: During 1 week of the study
measure: Concentration of local anesthetics used
timeFrame: During 1 week of the study
measure: Indications for RA
timeFrame: During 1 week of the study
measure: Technical management to perform RA
timeFrame: During 1 week of the study
measure: Technical management to perform RA
timeFrame: During 1 week of the study
measure: Technical management to perform RA
timeFrame: During 1 week of the study
measure: Technical management to perform RA
timeFrame: During 1 week of the study
measure: Evaluation of analgesia
timeFrame: During 1 week of the study
measure: Evaluation of success or not in RA
timeFrame: During 1 week of the study
measure: Contraindication for RA
timeFrame: During 1 week of the study
measure: Complication of RA
timeFrame: During 1 week of the study
measure: Reason for removal cathete
timeFrame: During 1 week of the study
measure: Duration of catheter
timeFrame: During 1 week of the study
measure: ICU/stepdown units length of stay
timeFrame: Day 28 after the RA
measure: Hospital length of stay
timeFrame: Day 28 after the RA
measure: Evaluation of vital status: on ICU/stepdown units discharge
timeFrame: Day 28 after the RA
measure: Evaluation of vital status at day 28
timeFrame: Day 28 after the RA
measure: Ventilator-free days to day 28
timeFrame: Day 28 after the RA
Other outcomes:
Locations:
city: Aix-En-Provence
country: France
facility: CH
city: Bry-sur-Marne
country: France
facility: CH
city: Chambéry
country: France
facility: CH
city: Clermont-Ferrand
country: France
facility: CHU
city: Clermont-Ferrand
country: France
facility: Centre Jean-Perrin
city: Grenoble
country: France
facility: CHU
city: Lille
country: France
facility: CHU
city: Lyon
country: France
facility: HCL Centre des Grands Brulés
city: Lyon
country: France
facility: HCL Hôpital Sud
city: Marseille
country: France
facility: APHM la Timone
city: Marseille
country: France
facility: APHM Nord
city: Nîmes
country: France
facility: CHU
city: Paris
country: France
facility: AHPH Saint-Antoine
city: Paris
country: France
facility: APHP Bichat
city: Reims
country: France
facility: CHU
city: Rennes
country: France
facility: CHU
city: Saint-Grégoire
country: France
facility: CH
city: Strasbourg
country: France
facility: CHU
city: Toulouse
country: France
facility: CHU
Study officials:
affiliation: rblondonnet@chu-clermontferrand.fr
name: Raïko Blondonnet
role: PRINCIPAL_INVESTIGATOR
References: