Pain, ChronicDOLOCHROREANCT02541851
Chronic Pain After Surgical Intensive Care Admission: Incidence and Risk Factors: the DOLOCHROREA Study
An observational study of Pain, Chronic and Intensive Care, Surgical, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The acute pain remains unfortunately a major health problem in intensive care patients. Several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or therapeutic procedure, could contribute to an increase in the incidence or in the intensity of acute pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Intensive Care, Surgical
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Sep 2016
- Phase
- Observational
- 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
Study population: Patients admitted in the surgical critical care unit of the Centre Hospitalier Universitaire de Besançon, France.
Who may be able to join
- Admission in the surgical critical care unit of the University Hospital of Besançon from February 2015
- Age over 18 yr old
- Informed consent
Who cannot join
- Age under 18 yr old
- Death within the first 6 months after the end of the stay in the surgical intensive unit of the University Hospital of Besançon
- Glasgow Coma Score under 8 at admission and/or at discharge
- Planned admission after elective surgery
- Medical history of cognitive disorder
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
The acute pain remains unfortunately a major health problem in intensive care patients. Several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or therapeutic procedure, could contribute to an increase in the incidence or in the intensity of acute pain. The acute pain could impact on the prognosis of intensive care patients and on the patients perception of the quality of care.
Moreover, the acute pain could lead to a long-term chronic pain syndrome. The chronic pain after intensive care admission could threaten the physical and psychological recovery after the stay in the intensive care unit (ICU).
Read more
If many studies have been conducted to improve the management of the acute pain in the ICU, only few data exist on the incidence and the risk factors of the chronic pain after a stay in a surgical intensive care.
The aim of the DOLOCHROREA study is to assess the incidence and the risk factors of 6-month chronic pain after a stay in our surgical ICU.
- Conditions
- Pain, Chronic, Intensive Care, Surgical
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic pain
Pain is defined by The International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage". Pain exceeding the average period of healing of 2 to 3 months and ceasing to serve any apparent protective function is defined as chronic pain. The incidence of chronic pain will be assessed by using a validated french version of the Brief Pain Inventory during a phone call at 6 month after the end of the stay in our intensive care unit.
Measured: 6 months
Secondary outcomes (2)
Incidence of anxiety and depression
The incidence of anxiety and depression at 6 months after the end of the stay in our intensive care unit will be assessed by using a validated french version of the Hospital Anxiety and Depression (HAD) scale during a phone call.
Measured: 6 months
Incidence of neuropathic pain
The incidence of neuropathic pain at 6 months after the end of the stay in our intensive care unit will assessed by using the DN4 tool during a phone call.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Insufficient recruitment leading to selection bias and insufficient data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume BESCH, Centre Hospitalier Universitaire de Besancon
- Investigators
- Guillaume Besch, M.D., Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541851
- Sponsor's protocol ID
- 15/03
- Acronym
- DOLOCHROREA
- Status last verified
- Aug 2017
- First submitted
- 3 Sep 2015
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Battle CE, Lovett S, Hutchings H. Chronic pain in survivors of critical illness: a retrospective analysis of incidence and risk factors. Crit Care. 2013 May 29;17(3):R101. doi: 10.1186/cc12746.
PubMed 23718685
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Surgical Intensive Care Admission: Incidence and Risk Factors: the DOLOCHROREA Study
- ClinicalTrials.gov ID
- NCT02541851
- Acronym / sponsor ID
- DOLOCHROREA / 15/03
- Conditions
- Pain, Chronic, Intensive Care, Surgical
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment leading to selection bias and insufficient data
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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 acute pain remains unfortunately a major health problem in intensive care patients. Several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or therapeutic procedure, could contribute to an increase in the incidence or in the intensity of acute pain. The acute pain could impact on the prognosis of intensive care patients and on the patients perception of the quality of care.
Moreover, the acute pain could lead to a long-term chronic pain syndrome. The chronic pain after intensive care admission could threaten the physical and psychological recovery after the stay in the intensive care unit (ICU).
If many studies have been conducted to improve the management of the acute pain in the ICU, only few data exist on the incidence and the risk factors of the chronic pain after a stay in a surgical intensive care.
The aim of the DOLOCHROREA study is to assess the incidence and the risk factors of 6-month chronic pain after a stay in our surgical ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in the surgical critical care unit of the Centre Hospitalier Universitaire de Besançon, France.
Key inclusion criteria (3 listed)
- Admission in the surgical critical care unit of the University Hospital of Besançon from February 2015
- Age over 18 yr old
- Informed consent
Key exclusion criteria (6 listed)
- Age under 18 yr old
- Death within the first 6 months after the end of the stay in the surgical intensive unit of the University Hospital of Besançon
- Glasgow Coma Score under 8 at admission and/or at discharge
- Planned admission after elective surgery
- Medical history of cognitive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of chronic pain
Time frame: 6 months
Pain is defined by The International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage". Pain exceeding the average period of healing of 2 to 3 months and ceasing to serve any apparent protective function is defined as chronic pain. The incidence of chronic pain will be assessed by using a validated french version of the Brief Pain Inventory during a phone call at 6 month after the end of the stay in our intensive care unit.
2 secondary outcomes
Incidence of anxiety and depression
Time frame: 6 months
Incidence of neuropathic pain
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Insufficient recruitment leading to selection bias and insufficient data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Background: PubMed 23718685Battle CE, Lovett S, Hutchings H. Chronic pain in survivors of critical illness: a retrospective analysis of incidence and risk factors. Crit Care. 2013 May 29;17(3):R101. doi: 10.1186/cc12746.
Related trials for Pain, Chronic
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Guillaume Besch, M.D. principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic and Intensive Care, Surgical, run by Centre Hospitalier Universitaire de Besancon 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 2 Aug 2017. 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 was stopped early (reason given: Insufficient recruitment leading to selection bias and insufficient data). Results are not available in the source record.
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?
Incidence of chronic pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02541851, which also lists 1 linked publication.
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 2 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.