Prevalence of Chronic Pain and Its Risk Factors After a Surgical Intensive Care Unit Stay. Prospective Observational Cohort

NCT04164342 | Completed

• 1 other identifier: 2019-A01865-52
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this observational, prospective study is to evaluate the incidence of chronic pain at 3 months after ICU discharge in patients with a prolonged ICU stay (i.e. ≥3 days). Investigators will assess the proportion of patients with chronic pain (defined according to the Brief Pain Inventory questionnaire), by interview at 3 months after ICU discharge. All data potentially associated with chronic pain will be collected, including the type of surgery, the acute pain (intensity and duration) during the ICU stay, the type and dose of opioids received, patients comorbidity... Patients will be follow-up at 6 and 12 months to identify impact on quality of life.

Conditions

Pain, Chronic; Critically Ill; Opioid-Related Disorders

Keywords

pain; critically ill

Outcome Measures

Primary Outcomes (1)

• Proportion of patients suffering from chronic pain 3 months after ICU discharge

  Proportion of patients with a Brief Pain Inventory questionnaire positive (answer "YES" at first question) at 3 months after ICU discharge

  3 months

Secondary Outcomes (2)

• Proportion of patients suffering from chronic pain at 6 and 12 months after ICU discharge discharge

  12 months

• Proportion of patients with possible depressive episode at 3, 6 and 12 months after ICU discharge

  12 months

Study Arms (1)

Single ARM

EXPERIMENTAL

This is an observational study, all patients will be followed at 3, 6 and 12 months by phone interviews to pass the Brief Pain Inventory (BPI) and the Patient Health Questionnaire-2 (PHQ-2) questionnaires (this is the intervention, since questionnaires at not usually done).

Other: surveys

Interventions

surveys OTHER

Phone interviews to pass the Brief Pain Inventory (BPI) and the Patient Health Questionnaire-2 (PHQ-2) questionnaires (this is the intervention, since questionnaires at not usually done) at 3, 6 and 12 months after ICU discharge.

Single ARM

Eligibility Criteria

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

You may qualify if:

• Adult patients
• Hospitalisation in ICU for ≥ 3 days
• Affiliation to French health care coverage
• Oral informed consent of the patient

You may not qualify if:

• Cancer with life expectancy \< 6 months
• Neurological status not allowing to answer surveys
• Pregnant, nursing or parturient women
• Adult deprived of liberty by court judgment or administrative
• Adult patient protected under the law (guardianship)
• Adult with forced psychiatric care

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, France

Location

MeSH Terms

Conditions

Chronic Pain; Critical Illness; Opioid-Related Disorders; Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sigismond SL Lasocki, PU-PH

  University Hospital, Angers

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 15, 2019
• Study Start: November 27, 2019
• Primary Completion: June 25, 2021
• Study Completion: July 26, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

FR (1)