Epidemiology of Chronic Pain as Part of the Post-intensive Care Syndrome (ALGO-REA)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Critical Care
• Intervention / Treatment: Other: Patients without chronic pain symptoms; Other: Patients with chronic pain symptoms

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.

• Study Type: Observational
• Enrollment (Actual): 1079

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months after the ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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)	Median 7 days
Pain management and risk factors in the ICU (Use of continuous intra-venous Morphine)	Binary information (yes/no)	Median 7 days
Pain management and risk factors in the ICU (Use of continuous intra-venous Ketamine)	Binary information (yes/no).	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).	Median 7 days
Pain management and risk factors in the ICU (Use of locoregional anesthesia)	Binary information (yes/no).	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)	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.	Median 7 days
Demographic data	Age; Sex; SAPS II; Type of ICU admission; Chronic Cardiovascular diseases: ischemic cardiomyopathy, hypertention; Chronic use of pain killers	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	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	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	ICU discharge (median 7 days)

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2021
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Pain; Critical Care; PICS; Post Intensive Care Syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: RC21_0020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No