Chronic PainDoul-CardNCT03412448
The Prevalence of Chronic Pain and Continued Opioid Use After Cardiac Surgery
An observational study of Chronic Pain and Cardiac Surgery, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
The authors propose to evaluate the prevalence of chronic post-operative pain (CPOP) and continued opioid use in the population that has undergone cardiac surgery at the Montreal Heart Institute. In addition, the authors wish to evaluate the presence of known risk factors for CPOP in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Cardiac Surgery, Opioid Use
- What is being tested?
- observation
- How many people
- 320 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 1 Aug 2018
- 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: population that has undergone cardiac surgery at the MHI.
Who may be able to join
- All patients who have surgery at the Montreal Heart Institute between October 1 2017 and October 1 2018 will be eligible for selection.
Who cannot join
- Patients who have declined to be contacted after surgery as noted on the MHI form "Consent for futur projects".
- All patients who accepted to be contacted but decline to participate when contacted after their surgery.
- Patients who cannot be reached by phone. Patients who cannot speak French
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Jennifer Cogan, MD, 514-376-3330 ext. 3732, cogan.jennifer@me.com
Michele Plante, PhD, 514-376-3330 ext. 3981, michele.plante@icm-mhi.org
About this study
Official title: The Prevalence of Chronic Pain and Continued Opioid Use After Cardiac
The authors propose to evaluate the prevalence of chronic post-operative pain (CPOP) and continued opioid use in the population that has undergone cardiac surgery at the Montreal Heart Institute. In addition, the authors wish to evaluate the presence of known risk factors for CPOP in this population.
Read the detailed description
This study will use a 15-minute telephone survey to prospectively evaluate the prevalence and intensity of chronic pain 6 months and 1 year after cardiac surgery. Data on the level of post-operative pain experienced on days 1 to 4, at the time of surgery, as well as opioid consumption, adjuvant pain treatments and other variables of interest that are currently recorded prospectively at time of surgery will be culled from patient charts. Additionally, the possibility of continued opioid use by patients at 6 months post-surgery will be evaluated.
- Conditions
- Chronic Pain, Cardiac Surgery, Opioid Use
- Being tested
- observation
- Keywords
- chronic pain, cardiac surgery, opioids
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
Observation,
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CPOP
Prevalence of CPOP at 6-months post-surgery.
Measured: 6 (+ or - two weeks) months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Jun 2017
- Primary completion15 Jun 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412448
- Sponsor's protocol ID
- 2017-2188
- Acronym
- Doul-Card
- Status last verified
- Jan 2018
- First submitted
- 19 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared
Publications
Choiniere M, Watt-Watson J. Persistent postoperative nonanginal pain after cardiac surgery. CMAJ. 2014 Aug 5;186(11):855. doi: 10.1503/cmaj.114-0057. No abstract available.
PubMed 25097223Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/archinternmed.2011.1827.
PubMed 22412106Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
PubMed 21955825
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Chronic Pain and Continued Opioid Use After Cardiac
- ClinicalTrials.gov ID
- NCT03412448
- Acronym / sponsor ID
- Doul-Card / 2017-2188
- Conditions
- Chronic Pain, Cardiac Surgery, Opioid Use
- Keywords
- chronic pain, cardiac surgery, opioids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 Jun 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 26 Jan 2018 (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 authors propose to evaluate the prevalence of chronic post-operative pain (CPOP) and continued opioid use in the population that has undergone cardiac surgery at the Montreal Heart Institute. In addition, the authors wish to evaluate the presence of known risk factors for CPOP in this population.
Detailed description
This study will use a 15-minute telephone survey to prospectively evaluate the prevalence and intensity of chronic pain 6 months and 1 year after cardiac surgery. Data on the level of post-operative pain experienced on days 1 to 4, at the time of surgery, as well as opioid consumption, adjuvant pain treatments and other variables of interest that are currently recorded prospectively at time of surgery will be culled from patient charts. Additionally, the possibility of continued opioid use by patients at 6 months post-surgery will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- population that has undergone cardiac surgery at the MHI.
Key inclusion criteria (1 listed)
- All patients who have surgery at the Montreal Heart Institute between October 1 2017 and October 1 2018 will be eligible for selection.
Key exclusion criteria (3 listed)
- Patients who have declined to be contacted after surgery as noted on the MHI form "Consent for futur projects".
- All patients who accepted to be contacted but decline to participate when contacted after their surgery.
- Patients who cannot be reached by phone. Patients who cannot speak French
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 |
|---|---|---|
| observationObservation, | Other | – |
Primary outcome
Prevalence of CPOP
Time frame: 6 (+ or - two weeks) months after surgery
Prevalence of CPOP at 6-months post-surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Background: PubMed 25097223Choiniere M, Watt-Watson J. Persistent postoperative nonanginal pain after cardiac surgery. CMAJ. 2014 Aug 5;186(11):855. doi: 10.1503/cmaj.114-0057. No abstract available.
- Background: PubMed 22412106Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/archinternmed.2011.1827.
- Background: PubMed 21955825Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
- Individual participant dataSharing planned: No. Data will not be shared
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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.
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 Chronic Pain and Cardiac Surgery, run by Montreal Heart Institute at 1 site in Canada.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jan 2018. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Cogan, MD (514-376-3330 ext. 3732, cogan.jennifer@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CPOP (time frame: 6 (+ or - two weeks) months after surgery). 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 NCT03412448, which also lists 3 linked publications.
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 26 Jan 2018.