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NCT Number: NCT04817696

Epidemiology of Chronic Pain as Part of the Post-intensive Care Syndrome

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.

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Key information

Conditions

Critical Care Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms postintensive care syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, 44000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients without chronic pain symptoms

Other

Verbal score < 3 at 3 months

Patients with chronic pain symptoms

Other

Verbal score ≥ 3 at 3 months

Primary outcomes

  1. Presence of pain (Simple Verbal Scale ≥3) persisting at 3 months after ICU admission

    Time frame: 3 months after the ICU admission

    Chronic pain is defined as a Simple Verbal Scale (ranging from 0 - no symptoms- to 10 - worst symptoms imaginable-) ≥ 3.

Secondary outcomes

  1. Intensity of pain, and risk factors associated with pain at 3 months after ICU admission

    Time frame: ICU discharge (median 7 days)

    The incidence of pain defined as a Simple Verbal Scale (ranging from 0 - no symptoms- to 10 - worst symptoms imaginable-) ≥ 3

  2. Type of pain (ie neuropathic)

    Time frame: ICU discharge (median 7 days) and at 3 months after admission

    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

  3. Pain management and risk factors in the ICU (Use of Remifentanyl)

    Time frame: Median 7 days

    Binary information (yes/no)

  4. Pain management and risk factors in the ICU (Use of continuous intra-venous Morphine)

    Time frame: Median 7 days

    Binary information (yes/no)

  5. Pain management and risk factors in the ICU (Use of continuous intra-venous Ketamine)

    Time frame: Median 7 days

    Binary information (yes/no).

  6. Pain management and risk factors in the ICU (Use of anti-hyperalgesia medication (ie : anti-epileptique drugs, gabapentine, tricyclic anti-depressive drugs))

    Time frame: Median 7 days

    Binary information (yes/no).

  7. Pain management and risk factors in the ICU (Use of locoregional anesthesia)

    Time frame: Median 7 days

    Binary information (yes/no).

  8. 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)

    Time frame: Median 7 days

    Binary information (yes/no)

  9. Pain management and risk factors in the ICU

    Time frame: Median 7 days

    • These outcomes and measures will be analyzed separately in the regression multivariable models of chronic pain and neuropathic pain.

  10. Demographic data

    Time frame: Baseline

    • Age
    • Sex
    • SAPS II
    • Type of ICU admission
    • Chronic Cardiovascular diseases: ischemic cardiomyopathy, hypertention
    • Chronic use of pain killers

  11. General ICU data (Length of invasive mechanical ventilation)

    Time frame: ICU discharge (median 7 days)

    Measured as the number of days between succesfull weaning of mechanical ventilation and initiation. Median duration : 7 days

  12. General ICU data

    Time frame: ICU discharge (median 7 days)

    • 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

  13. General ICU data ( Use of prone positionning during invasive mechanical ventilation)

    Time frame: ICU discharge (median 7 days)

    Binary information (yes/no). Median duration of monitoring :7 days

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Epidemiology of Chronic Pain as Part of Post-resuscitation Syndrome. Multicenter Prospective Non-interventional Study

Acronym: ALGO-REA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 26, 2021
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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