NCT04798573

Brief Summary

The investigators will approach elective cardiac and thoracic surgery patients in the preoperative consultation clinic. Consenting individuals will be administered, before surgery validated pain, psychological and sleep questionnaires. These questionnaires will be repeated at 3, 6 and 12 months postoperatively (PO) to follow up the progression of early PO pain and the transition to chronicity. Participants will define clinically relevant pain by calculating a chronic pain index (CPI). In addition, the investigators will follow the development of acute postsurgical and chronic pain from before surgery up to a year after, extract DNA from blood and contrast the genetic variations of participants with clinically significant chronic pain, to identify variations associated with the development of chronic post-surgical pain.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

August 3, 2012

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

12.3 years

First QC Date

January 7, 2021

Last Update Submit

July 2, 2025

Conditions

Chronic PainSurgery

Outcome Measures

Primary Outcomes (16)

  • Post-Surgical Pain Intensity

    Measured using the numeric rating scale (0=no pain; 10=worst pain imaginable)

    1 year from the day of surgery

  • Pain: Measured using the McGill Pain Questionnaire- Short Form-2 (SF-MPQ-2)

    The SF-MPQ-2 is a 22-item, expanded and revised version of the SF-MPQ designed to measure the qualities of neuropathic and non-neuropathic pain. Exploratory and confirmatory factor analyses revealed the presence of the following four factors or subscales: (1) continuous pain, (2) intermittent pain, (3) neuropathic pain, and (4) affective pain descriptor.

    1 year from the day of surgery

  • Pain: Measured using the Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (SLANSS)

    The S-LANSS is a validated 7-item questionnaire designed to distinguish whether pain is predominately neuropathic or nociceptive in origin.

    1 year from the day of surgery

  • Anxiety: Measured using the Anxiety Sensitivity Index-3 (ASI-3)

    The ASI-3 is a revised version of the widely used, 16-item scale ASI that measures concerns that anxiety and anxiety-related symptoms will lead to harmful negative consequences. Each item is rated on a 5-point scale ranging from very little (0) to very much (4).

    1 year from the day of surgery

  • Pain Catastrophizing: Measured using the Pain Catastrophizing Scale (PCS)

    The PCS consists of 13 items describing thoughts and feelings that individuals may experience when they are in pain. Each item is rated on a 5-point scale ranging from not at all (0) to all the time (4).

    1 year from the day of surgery

  • Pain Anxiety: Measured using the Pain Anxiety Symptoms Scale-20 (PASS-20)

    The PASS-20 is a shortened 20-item version of the original Pain Anxiety Symptoms Scale designed to measure fear and anxiety responses specific to pain, including avoidance. The PASS-20 has four 5-item subscales, including (1) cognitive anxiety, (2) escape and avoidance, (3) fearful thinking, and (4) physiological anxiety.

    1 year from the day of surgery

  • Pain Disability: Measured using the Pain Disability Index (PDI)

    The PDI assesses the extent to which persistent pain interferes with an individual's ability to engage in seven different areas of everyday activity including: (1) family/home responsibilities, (2) recreation, (3) social activity, (4) occupation, (5) sexual behavior, (6) self-care, and (7) life-support activity.

    1 year from the day of surgery

  • Posttraumatic Stress Disorder: Measured using the Posttraumatic Stress Disorder Checklist-Civilian Version (PCL-C)

    The Posttraumatic Stress Disorder Checklist - Civilian Version (PCL-C) is a 17-item self-report measure based on the current DSM-IV symptoms for PTSD. Respondents are asked to indicate how much they have been bothered by each symptom 5-point scale ranging from not at all (1) to extremely (5).

    1 year from the day of surgery

  • Anxiety and Depression: Measured using The Hospital Anxiety and Depression Scale (HADS)

    The HADS is the most widely used scale for measuring symptoms of anxiety and depression among medical inpatients, outpatients and the general population and consists of 7 anxiety and 7 depression-related items.

    1 year from the day of surgery

  • Somatization: Measured using the SCL-90-R-Somatization

    The SCL-90-R is a widely-used self-report symptom inventory measuring psychological symptoms of psychiatric and medical patients. Participants rate each item on a five-point scale of distress, ranging from 0 (no distress) to 4 (extreme distress).

    1 year from the day of surgery

  • Chronic Pain Acceptance: Measured using the Chronic Pain Acceptance Questionnaire (CPAQ)

    The CPAQ is a 20-item questionnaire that measures how participants react and adapt to living with chronic pain. Participants respond to "how true" each item is by selecting a number from 0 ("never true") to 6 ("always true").

    1 year from the day of surgery

  • Mindful Attention Awareness: Measured using the Mindful Attention Awareness Scale (MAAS)

    The MAAS is a 15-item scale designed to measure a central feature of dispositional mindfulness characterized by "open or receptive awareness of and attention to" the present. Participants respond to how frequently/infrequently they experience each item by selecting one of six response options on a Likert rating scale ranging from 1 ("Almost always") to 6 ("Almost never").

    1 year from the day of surgery

  • Pain Self Efficacy: Measured using the Pain Self-Efficacy Questionnaire (PSEQ)

    The PSEQ is a 10-item Likert-type questionnaire, designed specifically for chronic pain, where patients are asked to rate their confidence to complete certain activities despite pain.

    1 year from the day of surgery

  • Sensitivity to Pain Traumatization: Measured using the Sensitivity to Pain Traumatization Scale (SPTS)

    The SPTS is a 12-item questionnaire that was designed to measure the anxiety-related cognitive, emotional and behavioural reactions to pain that resemble symptoms of a traumatic stress reaction. Each item is rated on a 5-item Likert scale (from 1 (not at all true) to 5 (entirely true)).

    1 year from the day of surgery

  • Sleep Problems: Measured using the Sleep Problems Questionnaire

    This is a general questionnaire that asks its questions providing responses in units of days.

    1 year from the day of surgery

  • Sleep Quality: Measured using the Pittsburg Sleep Quality Index (PQSI)

    The PSQI questionnaire is much more specific, identifying specific responses and reasons why patients may be having trouble sleeping such as: (1) cannot get to sleep within 30 minutes and (2) wake up in the middle of the night or early morning.

    1 year from the day of surgery

Secondary Outcomes (7)

  • Physical Activity for Thoracic Patients: Measured using Actiwatch--64

    Up to 11 days from surgery

  • Sleep Quality for Thoracic Patients: Measured using the Sleep Quality Assessment

    Up to 11 days from surgery

  • Mechanical Pain Pressure: Measured using the Mechanical Pressure Pain Threshold (PPT)

    1 year from the day of surgery

  • Thermal Pain and Sensory: Measured using the Thermal Pain and Sensory Thresholds

    1 year from the day of surgery

  • Pain Illusion: Measured using the Thermal Grill Illusion Test

    1 year from the day of surgery

  • +2 more secondary outcomes

Other Outcomes (1)

  • Genotyping Outcomes- DNA and Biomarkers

    From pre-surgery to 3 month post-surgically

Eligibility Criteria

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

Elective cardiac and thoracic surgery patients who agree to participate in the study

You may qualify if:

  • Age ≥ 18 years
  • Non- Emergency Cardiac Surgery with Midline Sternotomy OR Thoracic Surgery via VATS or Lateral Thoracotomy
  • Written informed consent to participate in the study

You may not qualify if:

  • Patient unable to understand the study protocol
  • History of a psychotic psychiatric disorder
  • Unable to speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (118)

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Biospecimen

Retention: SAMPLES WITH DNA

We will extract DNA from blood and contrast the genetic variations of participants with clinically significant chronic pain, to identify variations associated with the development of chronic post-surgical pain.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hance Clarke, MD PhD FRCPC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 7, 2021

First Posted

March 15, 2021

Study Start

August 3, 2012

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)