Clinical trial NCT04817696: Epidemiology of Chronic Pain as Part of the Post-intensive Care Syndrome
Official title: Epidemiology of Chronic Pain as Part of Post-resuscitation Syndrome. Multicenter Prospective Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Chronic Pain
Keywords: PICS
Post Intensive Care Syndrome
Chronic Pain
Critical Care
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 1079
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria :

* All patients admitted in ICU
* ICU length-of-stay ≥ 48 hours
* No major cognitive impairment that could prevent pain evaluation

Exclusion Criteria :

* Patient under 18-year-old
* Patient under guardianship
* Patient unable to communicate or quantify pain with a Verbal Score and ID-Pain score
* Refusal to participate

Primary outcomes:
measure: Presence of pain (Simple Verbal Scale ≥3) persisting at 3 months after ICU admission
timeFrame: 3 months after the ICU admission
Secondary outcomes:
measure: Intensity of pain, and risk factors associated with pain at 3 months after ICU admission
timeFrame: ICU discharge (median 7 days)
measure: Type of pain (ie neuropathic)
timeFrame: ICU discharge (median 7 days) and at 3 months after admission
measure: Pain management and risk factors in the ICU (Use of Remifentanyl)
timeFrame: Median 7 days
measure: Pain management and risk factors in the ICU (Use of continuous intra-venous Morphine)
timeFrame: Median 7 days
measure: Pain management and risk factors in the ICU (Use of continuous intra-venous Ketamine)
timeFrame: Median 7 days
measure: Pain management and risk factors in the ICU (Use of anti-hyperalgesia medication (ie : anti-epileptique drugs, gabapentine, tricyclic anti-depressive drugs))
timeFrame: Median 7 days
measure: Pain management and risk factors in the ICU (Use of locoregional anesthesia)
timeFrame: Median 7 days
measure: 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)
timeFrame: Median 7 days
measure: Pain management and risk factors in the ICU
timeFrame: Median 7 days
measure: Demographic data
timeFrame: Baseline
measure: General ICU data (Length of invasive mechanical ventilation)
timeFrame: ICU discharge (median 7 days)
measure: General ICU data
timeFrame: ICU discharge (median 7 days)
measure: General ICU data ( Use of prone positionning during invasive mechanical ventilation)
timeFrame: ICU discharge (median 7 days)
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References: