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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03412448
Other study ID # 2017-2188
Secondary ID
Status Recruiting
Phase N/A
First received January 19, 2018
Last updated January 19, 2018
Start date June 1, 2017
Est. completion date August 1, 2018

Study information

Verified date January 2018
Source Montreal Heart Institute
Contact Jennifer Cogan, MD
Phone 514-376-3330
Email cogan.jennifer@me.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date August 1, 2018
Est. primary completion date June 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

All patients who have surgery at the Montreal Heart Institute between October 1 2017 and October 1 2018 will be eligible for selection.

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
observation
Observation,

Locations

Country Name City State
Canada Montreal Heart Institute Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Alam 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. — View Citation

Choinière M, Watt-Watson J. Persistent postoperative nonanginal pain after cardiac surgery. CMAJ. 2014 Aug 5;186(11):855. doi: 10.1503/cmaj.114-0057. — View Citation

Mazzeffi 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of CPOP Prevalence of CPOP at 6-months post-surgery. 6 (+ or - two weeks) months after surgery
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