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

Primary Purpose

Pain, Chronic, Critically Ill, Opioid-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
surveys
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Chronic focused on measuring pain, critically ill

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient with chronic pain at inclusion :defined as a prescription of pain killers (level 2 or 3), for more than 3 months
  • 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

Sites / Locations

  • CHU Angers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single ARM

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients suffering from chronic pain at 6 and 12 months after ICU discharge discharge
Proportion of patients with a Brief Pain Inventory questionnaire positive (answer "YES" at first question) 6 and 12 months after ICU discharge
Proportion of patients with possible depressive episode at 3, 6 and 12 months after ICU discharge
Proportion of patients with a score A ≥ 3 ( PHQ-2 score ranges from 0-6). If the score is 3 or greater, major depressive disorder is likely.Patient Health Questionnaire 2 (PHQ 2)

Full Information

First Posted
November 5, 2019
Last Updated
July 26, 2022
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04164342
Brief Title
Prevalence of Chronic Pain and Its Risk Factors After a Surgical Intensive Care Unit Stay. Prospective Observational Cohort
Acronym
DOUCREA
Official Title
Etude de la prévalence de la Douleur Chronique et de Ses Facteurs de Risque après Une Hospitalisation en réanimation Chirurgicale
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Acute pain is common for ICU patients, with an incidence of 33% at rest and of 56% during nursing care. However, there is few if any data on chronic pain after an ICU stay (ie lasting more than 3 months after ICU discharge), while chronic pain seems to be frequent in patients, in particular following surgeries. Indeed, several studies have shown that in postoperative period, many patients suffer from chronic pains, with incidence from 12 to more than 50 %, depending on surgery. Known risk factors include: Female gender young age mental disorder antecedent pain prior to surgery type of anesthesia, including the type and dose of opioids used not correctly controlled severe pain prolonged pain Chronic pain is becoming a public health problem, because of its impact on patients quality of life, but also on the over consumption of opioids as a result, and the addiction that arise. Chronic pain following an ICU stay as been studied so far. Available studies in ICU are mainly interested in the quality of life, which remains altered even many years after ICU discharge. The most popular survey is the SF-36 which includes a section on chronic pain. However no study, to the best of our knowledge, were interested in chronic pain prevalence and in its risk factors after an ICU stay. In our surgical ICU unit, there is two sedation-analgesia protocols, that use different types of opioids (ie sufentanyl or Remifentanyl), in addition physicians may prescribe morphine for awake patients or other oral opioids. The impact of opioid choice on chronic pain prevalence after ICU discharge is not known today, but could be important, as it is for postoperative chronic pain. We hypothesis that chronic pain is frequent after a surgical ICU stay and that some factors may be associated with it, including the type of opioids received. The investigators will conduct a prospective observational study to evaluate this prevalence and the risk factors associated with chronic pain following a prolonged ICU stay. Patients with an ICU stay ≥3 days, capable to answer to questionnaires will be eligible and will be invited to participate to the study just before their discharge from ICU. After inclusion, patient's conditions prior to ICU stay, type od admission, all critical care events, pain (duration and intensity), treatments (including opioids)... will be collected. Investigators will pass the Brief Pain Inventory (BPI) questionnaire A to the patients before discharge from ICU. Investigators will phone the patient at 3 (primary endpoint), 6 and 12 months after ICU discharge, in order to fill BPI questionnaire for chronic pain diagnosis, to evaluate its impact on quality of life, to fill PHQ 2 survey and record all pain treatment. Beside those 3 phone calls, there is no change in patient care, but patients can be offered to consult their doctor in case of chronic pain screening or presence of depressive symptoms. This study will allow to characterise chronic pain incidence after an hospitalisation period of at least 3 days in surgical ICU, and to better define possible risk factors. Some risk factors of chronic pain could be modifiable, in particular the type of opioid received. Identification of risk factors for chronic pain could help identifying patients who could benefit from specific care or from post-ICU follow-up consultations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Critically Ill, Opioid-Related Disorders
Keywords
pain, critically ill

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single ARM
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
surveys
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients suffering from chronic pain 3 months after ICU discharge
Description
Proportion of patients with a Brief Pain Inventory questionnaire positive (answer "YES" at first question) at 3 months after ICU discharge
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Proportion of patients suffering from chronic pain at 6 and 12 months after ICU discharge discharge
Description
Proportion of patients with a Brief Pain Inventory questionnaire positive (answer "YES" at first question) 6 and 12 months after ICU discharge
Time Frame
12 months
Title
Proportion of patients with possible depressive episode at 3, 6 and 12 months after ICU discharge
Description
Proportion of patients with a score A ≥ 3 ( PHQ-2 score ranges from 0-6). If the score is 3 or greater, major depressive disorder is likely.Patient Health Questionnaire 2 (PHQ 2)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients Hospitalisation in ICU for ≥ 3 days Affiliation to French health care coverage Oral informed consent of the patient Exclusion Criteria: Patient with chronic pain at inclusion :defined as a prescription of pain killers (level 2 or 3), for more than 3 months 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigismond SL Lasocki, PU-PH
Organizational Affiliation
University Hospital, Angers
Official's Role
Study Director
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France

12. IPD Sharing Statement

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

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