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

NCT04817696 | Completed

• 1 other identifier: RC21_0020
• Study Type: observational
• Target: 1,079
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Care; Chronic Pain

Keywords

PICS; Post Intensive Care Syndrome; Chronic Pain; Critical Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

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

  ICU discharge (median 7 days)

• Type of pain (ie neuropathic)

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

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

  Median 7 days

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

  Median 7 days

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

  Median 7 days

Interventions

Patients with chronic pain symptoms OTHER

Verbal score ≥ 3 at 3 months

Patients without chronic pain symptoms OTHER

Verbal score \< 3 at 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44000, France

Location

Related Publications (1)

• Bourdiol A, Legros V, Vardon-Bounes F, Rimmele T, Abraham P, Hoffmann C, Dahyot-Fizelier C, Jonas M, Bouju P, Cirenei C, Launey Y, Le Gac G, Boubeche S, Lamarche E, Huet O, Bezu L, Darrieussecq J, Szczot M, Delbove A, Schmitt J, Lasocki S, Auchabie J, Petit L, Kuhn-Bougouin E, Asehnoune K, Ingles H, Roquilly A, Cinotti R; ALGO-REA study group; Atlanrea Group; Societe Francaise d'Anesthesie-Reanimation-SFAR Research Network. Prevalence and risk factors of significant persistent pain symptoms after critical care illness: a prospective multicentric study. Crit Care. 2023 May 25;27(1):199. doi: 10.1186/s13054-023-04491-w.

  PMID: 37226261 DERIVED

MeSH Terms

Conditions

Chronic Pain; postintensive care syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: March 26, 2021
• Study Start: April 25, 2021
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)