Pain, ChronicDOUCREANCT04164342
Prevalence of Chronic Pain and Its Risk Factors After a Surgical Intensive Care Unit Stay. Prospective Observational Cohort
A study testing surveys in people with Pain, Chronic and Critically Ill, run by University Hospital, Angers at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Critically Ill, Opioid-Related Disorders
- What is being tested?
- surveys
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2019to 26 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Hospitalisation in ICU for ≥ 3 days
- Affiliation to French health care coverage
- Oral informed consent of the patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude de la prévalence de la Douleur Chronique et de Ses Facteurs de Risque après Une Hospitalisation en réanimation Chirurgicale
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.
Read the 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.
- Conditions
- Pain, Chronic, Critically Ill, Opioid-Related Disorders
- Being tested
- surveys
- Keywords
- pain, critically ill
- Medical subject headings
- Chronic Pain, Critical Illness, Opioid-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveysOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (2)
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
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start27 Nov 2019
- Primary completion25 Jun 2021
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sigismond SL Lasocki, PU-PH, Study director, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164342
- Sponsor's protocol ID
- 2019-A01865-52
- Acronym
- DOUCREA
- Status last verified
- Jul 2022
- First submitted
- 5 Nov 2019
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de la prévalence de la Douleur Chronique et de Ses Facteurs de Risque après Une Hospitalisation en réanimation Chirurgicale
- ClinicalTrials.gov ID
- NCT04164342
- Acronym / sponsor ID
- DOUCREA / 2019-A01865-52
- Conditions
- Pain, Chronic, Critically Ill, Opioid-Related Disorders
- Keywords
- pain, critically ill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single ARM | Experimental | Other: surveysThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients
- Hospitalisation in ICU for ≥ 3 days
- Affiliation to French health care coverage
- Oral informed consent of the patient
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveysPhone 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. | Other | Single ARM |
Primary outcome
Proportion of patients suffering from chronic pain 3 months after ICU discharge
Time frame: 3 months
Proportion of patients with a Brief Pain Inventory questionnaire positive (answer "YES" at first question) at 3 months after ICU discharge
2 secondary outcomes
Proportion of patients suffering from chronic pain at 6 and 12 months after ICU discharge discharge
Time frame: 12 months
Proportion of patients with possible depressive episode at 3, 6 and 12 months after ICU discharge
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigismond SL Lasocki, PU-PH study director
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surveys in people with Pain, Chronic and Critically Ill, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients suffering from chronic pain 3 months after ICU discharge (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.