An observational study in Critical Care and Chronic Pain, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-18.
Sponsored by Nantes University Hospital · Observational
Post-intensive care syndrome is an entity of cognitive, physical and mental health disorders occurring and persisting after ICU discharge and responsible of disabilities and decrease of quality of life. Nowadays mental and cognitive health impairments appear to be well known but few data are available about chronic pain after a critical care illness. The aim of the study is to determine the incidence and the risks factors of chronic pain after ICU.
Post-intensive care syndrome is receiving growing interest because of the chronic health issues secondary to a critical care admission: neurocognitive impairment, motor sequelae, mood disturbances. These chronic health issues bear tremendous burden for patients and next-of-kin. Among these chronic health issues, chronic pain symptoms could have major consequences on the patient's quality of life. In the local single-center follow-up experience, 6 months after a patient's admission in the critical care unit, around 20% of patients displayed chronic pain symptoms. The investigators have addressed these patients to pain care specialists, with successful treatment success. However, the evaluation of pain symptoms remains simplistic; moreover, the incidence of chronic pain symptoms in patients after critical care unit admission, receives little attention in the literature although these symptoms may literally blunt out all other health issues. The incidence and type of chronic pain symptoms has been poorly described, to the best of knowledge.
The aim of this study is to perform a multi-center nationwide epidemiologic study of chronic pain symptoms after a critical care unit admission. The investigators intend to describe the incidence of chronic pain assessed with a Simple Verbal Score ≥ 3, 3 months after the ICU admission. The investigators also intend to describe the incidence of painful symptoms, at ICU discharge as well as the type of pain symptoms (ie neuropathic pain) at discharge and at 3 months using the ID-Pain scale. The evaluation at 3 months will be performed during a physical follow-up or self-assessed by the patient. The investigators intend to explore the risk factors associated with chronic pain, as an exploratory analysis.
The investigators are performing a nation-wide multicentric study. At this point 24 centers are participating to this study and the investigators expect to include 700 patients with a 3 months follow-up.
2,928 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's enrollment of 1,079 is above the median of 126 across 687 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients admitted in ICU with a length of stay > 48 hours and without major cognitive impairment that could prevent an accurate evaluation of pain
Exclusion Criteria :
Verbal score \< 3 at 3 months
Verbal score ≥ 3 at 3 months
Presence of pain (Simple Verbal Scale ≥3) persisting at 3 months after ICU admission
Chronic pain is defined as a Simple Verbal Scale (ranging from 0 - no symptoms- to 10 - worst symptoms imaginable-) ≥ 3.
Time frame: 3 months after the ICU admission
Intensity of pain, and risk factors associated with pain at 3 months after ICU admission
The incidence of pain defined as a Simple Verbal Scale (ranging from 0 - no symptoms- to 10 - worst symptoms imaginable-) ≥ 3
Time frame: ICU discharge (median 7 days)
Type of pain (ie neuropathic)
The Type of pain will be assessed with the score ID-Pain at ICU discharge, and 3 months after discharge. The ID-Pain is a 6-item scores that characterizes pain.The score ranges from 0 to 5. A score of 2-3 is predictive of a probable neuropathic pain and a score of 4-5 is highly associated with a neuropathic pain. Pain assessment tools require an auto-evaluation, performed by the patient
Time frame: ICU discharge (median 7 days) and at 3 months after admission
Pain management and risk factors in the ICU (Use of Remifentanyl)
Binary information (yes/no)
Time frame: Median 7 days
Pain management and risk factors in the ICU (Use of continuous intra-venous Morphine)
Binary information (yes/no)
Time frame: Median 7 days
Pain management and risk factors in the ICU (Use of continuous intra-venous Ketamine)
Binary information (yes/no).
Time frame: Median 7 days
Pain management and risk factors in the ICU (Use of anti-hyperalgesia medication (ie : anti-epileptique drugs, gabapentine, tricyclic anti-depressive drugs))
Binary information (yes/no).
Time frame: Median 7 days
Pain management and risk factors in the ICU (Use of locoregional anesthesia)
Binary information (yes/no).
Time frame: Median 7 days
Pain management and risk factors in the ICU (Type surgery and invasive procedures during ICU: Neurosurgery, orthopedic surgery spine surgery, abdominal surgery, thoracic surgery, thoracic drain)
Binary information (yes/no)
Time frame: Median 7 days
Pain management and risk factors in the ICU
• These outcomes and measures will be analyzed separately in the regression multivariable models of chronic pain and neuropathic pain.
Time frame: Median 7 days
Demographic data
* Age * Sex * SAPS II * Type of ICU admission * Chronic Cardiovascular diseases: ischemic cardiomyopathy, hypertention * Chronic use of pain killers
Time frame: Baseline
General ICU data (Length of invasive mechanical ventilation)
Measured as the number of days between succesfull weaning of mechanical ventilation and initiation. Median duration : 7 days
Time frame: ICU discharge (median 7 days)
General ICU data
• ARDS. Defined as a PaO2/FiO2 ratio \< 300mmHg, according to the Berlin definition (JAMA 2012). Binary information (yes/no). Median duration of monitoring : 7 days
Time frame: ICU discharge (median 7 days)
General ICU data ( Use of prone positionning during invasive mechanical ventilation)
Binary information (yes/no). Median duration of monitoring :7 days
Time frame: ICU discharge (median 7 days)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nantes University Hospital