NCT03412448

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

January 19, 2018

Last Update Submit

January 19, 2018

Conditions

Keywords

chronic paincardiac surgeryopioids

Outcome Measures

Primary Outcomes (1)

  • Prevalence of CPOP

    Prevalence of CPOP at 6-months post-surgery.

    6 (+ or - two weeks) months after surgery

Interventions

Observation,

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

population that has undergone cardiac surgery at the MHI.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Related Publications (3)

  • 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.

    PMID: 25097223BACKGROUND
  • 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.

    PMID: 22412106BACKGROUND
  • 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. No abstract available.

    PMID: 21955825BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Observation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Jennifer Cogan, MD

CONTACT

Michelle Plante, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 26, 2018

Study Start

June 1, 2017

Primary Completion

June 15, 2018

Study Completion

August 1, 2018

Last Updated

January 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Data will not be shared

Locations