Intensive Care UnitWeek'ALRNCT05131633
Regional Anaesthesia in Intensive Care Unit
An observational study of Intensive Care Unit, run by University Hospital, Clermont-Ferrand at 19 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit
- How many people
- 100 participants
- Where
- 19 sitesFrance
- Study dates
- 18 Oct 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All medical, surgical, and trauma patients hospitalized in the participating centers and receiving RA during the one-week study period.
Who may be able to join
- ○ All medical, surgical, and trauma patients hospitalized in the participating centers and receiving RA during the one-week study period.
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
CH
Aix-en-Provence
CH
Bry-sur-Marne
CH
Chambéry
CHU
Clermont-Ferrand, 63000
Centre Jean-Perrin
Clermont-Ferrand
CHU
Grenoble
CHU
Lille
HCL Centre des Grands Brulés
Lyon
HCL Hôpital Sud
Lyon
APHM la Timone
Marseille
APHM Nord
Marseille
CHU
Nîmes
AHPH Saint-Antoine
Paris
APHP Bichat
Paris
CHU
Reims
CHU
Rennes
CH
Saint-Grégoire
CHU
Strasbourg
CHU
Toulouse
About this study
Official title: 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.
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.
- Conditions
- Intensive Care Unit
- Keywords
- regional anesthesia, intensive care unit, analgesia, pain management
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 1 week of the study
Secondary outcomes (22)
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
Measured: During 1 week of the study
Type of RA
Nerves block or spinal anesthesia or epidural anesthesia
Measured: During 1 week of the study
Location of RA
ICU or step-down unit or operating room
Measured: During 1 week of the study
Who perform RA
Resident or senior and intensivist or anesthesiologist
Measured: During 1 week of the study
Name of local anesthetics used
Name of local anesthetics used
Measured: During 1 week of the study
Concentration of local anesthetics used
Concentration in mg/ml
Measured: During 1 week of the study
Indications for RA
Analgesia or anesthesia or mobilization or nursing or weaning from mechanical ventilation
Measured: During 1 week of the study
Technical management to perform RA
Type of needle
Measured: During 1 week of the study
Technical management to perform RA
Use of sonography (yes / no)
Measured: During 1 week of the study
Technical management to perform RA
Use of electrical nerve stimulator (yes / no)
Measured: During 1 week of the study
Technical management to perform RA
Use of continuous catheter (yes / no)
Measured: During 1 week of the study
Evaluation of analgesia
Visual Analog Score for pain)
Measured: During 1 week of the study
Evaluation of success or not in RA
Sensitive and/or motor block
Measured: During 1 week of the study
Contraindication for RA
Type of contraindication
Measured: During 1 week of the study
Complication of RA
Type of complication
Measured: During 1 week of the study
Reason for removal cathete
Type of reason
Measured: During 1 week of the study
Duration of catheter
Duration in days
Measured: During 1 week of the study
ICU/stepdown units length of stay
Length in days
Measured: Day 28 after the RA
Hospital length of stay
Length in days
Measured: Day 28 after the RA
Evaluation of vital status: on ICU/stepdown units discharge
Measured: Day 28 after the RA
Evaluation of vital status at day 28
Death or alive
Measured: Day 28 after the RA
Ventilator-free days to day 28
Unit : days
Measured: Day 28 after the RA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start18 Oct 2021
- Primary completion20 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Blondonnet Raïko, University Hospital, Clermont-Ferrand
- Investigators
- Raïko Blondonnet, Principal investigator, rblondonnet@chu-clermontferrand.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131633
- Sponsor's protocol ID
- WEEK'ALR
- Acronym
- Week'ALR
- Status last verified
- Feb 2023
- First submitted
- 3 Oct 2021
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Regional Anaesthesia in Intensive Care Unit. A Multicentric Professional Practice Evaluation
- ClinicalTrials.gov ID
- NCT05131633
- Acronym / sponsor ID
- Week'ALR / WEEK'ALR
- Conditions
- Intensive Care Unit
- Keywords
- regional anesthesia, intensive care unit, analgesia, pain management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- 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
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All medical, surgical, and trauma patients hospitalized in the participating centers and receiving RA during the one-week study period.
Key inclusion criteria (1 listed)
- ○ All medical, surgical, and trauma patients hospitalized in the participating centers and receiving RA during the one-week study period.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
22 secondary outcomes
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
Type of RA
Time frame: During 1 week of the study
Location of RA
Time frame: During 1 week of the study
Who perform RA
Time frame: During 1 week of the study
Name of local anesthetics used
Time frame: During 1 week of the study
Concentration of local anesthetics used
Time frame: During 1 week of the study
Indications for RA
Time frame: During 1 week of the study
Technical management to perform RA
Time frame: During 1 week of the study
Technical management to perform RA
Time frame: During 1 week of the study
Technical management to perform RA
Time frame: During 1 week of the study
Technical management to perform RA
Time frame: During 1 week of the study
Evaluation of analgesia
Time frame: During 1 week of the study
Evaluation of success or not in RA
Time frame: During 1 week of the study
Contraindication for RA
Time frame: During 1 week of the study
Complication of RA
Time frame: During 1 week of the study
Reason for removal cathete
Time frame: During 1 week of the study
Duration of catheter
Time frame: During 1 week of the study
ICU/stepdown units length of stay
Time frame: Day 28 after the RA
Hospital length of stay
Time frame: Day 28 after the RA
Evaluation of vital status: on ICU/stepdown units discharge
Time frame: Day 28 after the RA
Evaluation of vital status at day 28
Time frame: Day 28 after the RA
Ventilator-free days to day 28
Time frame: Day 28 after the RA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raïko Blondonnet principal investigator
rblondonnet@chu-clermontferrand.fr
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit, run by University Hospital, Clermont-Ferrand at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Our primary objective is to assess the global use of RA in ICU/stepdown units (time frame: During 1 week of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023; AzTrials last refreshed its copy on 1 Nov 2026.