Regional Anaesthesia in Intensive Care Unit

Intensive Care Unit Clinical Trial

— Week'ALR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05131633
• Other study ID #: WEEK'ALR
• Status: Completed
• Start date: October 18, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: November 20, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit

Locations

Country	Name	City	State
France	CH	Aix-En-Provence
France	CH	Bry-sur-Marne
France	CH	Chambéry
France	Centre Jean-Perrin	Clermont-Ferrand
France	CHU	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

Sponsors (19)

Lead Sponsor

Collaborator

University Hospital, Clermont-Ferrand

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

Country where clinical trial is conducted

France, 

Outcome

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