Incidence and Risk Factors for Persistent Post-sternotomy Pain After Cardiac Surgery in Local Chinese Population: a Prospective Cohort Study

August 29, 2023 updated by: WONG MAN KIN, Chinese University of Hong Kong

CPSP is common after cardiac surgery. The reported incidence was 28% to 56% up to 2 years postoperatively. Despite a large number of cross-sectional and retrospective studies, prospective cohort studies examining the incidence of chronic post-sternotomy pain following cardiac surgery have been scarce, and none on our local Chinese population.

Several mechanisms have been involved in the development of chronic pain after sternotomy. Ongoing pain after surgery can continue to sensitize the nociceptive fibres which may subsequently lead to hyperalgesia, hyperpathia, allodynia and dysesthesia. In addition, like any form of chronic pain, it is a multidimensional process involving social, cognitive and psychological factors.

CPSP has the potential to impact daily functioning and quality of life of patients, as well as increasing the healthcare costs. To date, only the CARDpain study examined the role of social and psychological risk factors in development of CPSP after cardiac surgery. They found pre-surgical anxiety, measured by the Hospital and Anxiety Depression Scale (HADS), was a significant risk factor.

The primary aim of the study is to examine the incidence of chronic post-sternotomy pain at 3 months and 6 months following cardiac surgery in local Chinese population, and identify the clinical and psychological risk factors associated with its development. The secondary aim is to determine the impact of CPSP on the quality of life following cardiac surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Postoperative pain that persists beyond the normal time for tissue healing is increasingly recognized as an important complication after various types of surgery. According to the International Association for Study of Pain (IASP), chronic postsurgical pain (CPSP) is defined as the persistence of pain at surgical site or referred area, at least 3 months following the surgical procedure1. CPSP is common after cardiac surgery. The reported incidence was 28% to 56% up to 2 years postoperatively. The wide range of reported incidence seems to result from heterogenicity of the study population and the study design. McGillion MH et al reviewed that cross-sectional and retrospective studies have generally reported higher prevalence for CPSP (14-56%) after cardiac surgery than those investigations with prospective designs (7.5-45%). Despite a large number of cross-sectional and retrospective studies, prospective cohort studies examining the incidence of chronic post-sternotomy pain following cardiac surgery have been scarce, and none on our local Chinese population.

Several mechanisms have been involved in the development of chronic pain after sternotomy. These include dissection, nerve entrapment by sternal wires, sternal retraction which can dislocate and fractured ribs, and intercostal neuralgia as a consequence of nerve damage during dissection of the internal mammary artery during coronary artery bypass graft (CABG). All can stimulate the release of proinflammatory cytokines which sensitize the afferent nociceptive fibres to cause chronic pain. Ongoing pain after surgery can continue to sensitize the nociceptive fibres which may subsequently lead to hyperalgesia, hyperpathia, allodynia and dysesthesia. In addition, like any form of chronic pain, it is a multidimensional process involving social, cognitive and psychological factors.

CPSP has the potential to impact daily functioning and quality of life of patients, as well as increasing the healthcare costs. CARDpain study reported that among those with CPSP, over 50% had significant pain-related interference with activities of daily living (family and home responsibilities, recreation and employment) at 3, 6 and 12 months following cardiac surgery. Identification of risk factors associated with the development of CPSP could potentially improve outcomes among high-risk patients, especially if the risk factors are modifiable. To date, only the CARDpain study examined the role of social and psychological risk factors in development of CPSP after cardiac surgery. They found pre-surgical anxiety, measured by the Hospital and Anxiety Depression Scale (HADS), was a significant risk factor.

The primary aim of our study is to examine the incidence of chronic post-sternotomy pain at 3 months and 6 months following cardiac surgery in our local Chinese population, and identify the clinical and psychological risk factors associated with its development. The secondary aim is to determine the impact of CPSP on the quality of life following cardiac surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Henry Man Kin WONG, MBChB
  • Phone Number: +852 556995590
  • Email: mkw118@gmail.com

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Local Chinese population age 18 or older undergoing elective open heart surgery

Description

Inclusion Criteria:

  1. Adult patients aged 18 or older
  2. Elective surgery
  3. Primary isolated coronary artery bypass grafting, aortic valve repair/replacement or combined coronary artery bypass/valve procedure via sternotomy for the first time

Exclusion Criteria:

  1. Emergency surgery
  2. Redo surgery
  3. History of thoracotomy or mastectomy
  4. History of psychosis or illicit drug use
  5. Estimated glomerular filtration rate (eGFR) <30ml/min or on renal replacement therapy. This is calculated using Cockcroft-Gault formula
  6. Intraoperative use of remifentanil
  7. Unable to provide informed consent and complete the questionnaires because of physical or mental incapacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of chronic post-sternotomy pain in number
Time Frame: 3 months after surgery
Number of recruited patients who have chronic pain
3 months after surgery
Incidence of chronic post-sternotomy pain in percentage
Time Frame: 3 months after surgery
Percentage of recruited patients who have chronic pain
3 months after surgery
Incidence of chronic post-sternotomy pain
Time Frame: 6 months after surgery
Number of recruited patients who have chronic pain
6 months after surgery
Incidence of chronic post-sternotomy pain
Time Frame: 6 months after surgery
Percentage of recruited patients who have chronic pain
6 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Association between the severity of acute postoperative pain (measured using visual analogue scale) and the presence of chronic post-surgical pain
Time Frame: Acute postoperative pain captured within 72 hours and on Day 7 after surgery using visual analogue score
Pain score assessment using visual analogue scale. The score ranges from 0 to 10. The severity of pain increases with the score. Statistical analysis will be used to identify the associate between acute pain and chronic post-surgical pain in cardiac surgical patients.
Acute postoperative pain captured within 72 hours and on Day 7 after surgery using visual analogue score
Association between the amount of intraoperative and postoperative opioid consumption and the presence of chronic post-surgical pain
Time Frame: Opioid consumption during surgery and within 72 hours after surgery will be captured
Total opioid consumption intraoperatively and postoperatively in ICU and ward will be recorded. Intraoperative opioid consumption can be extracted from the anesthetic record. Postoperative opioid consumption can be recorded from the Patient-controlled Analgesia machine. The dose of all opioids used will be converted into morphine equivalent dose. Regression analysis will be used to identify the relationship between opioid consumption and chronic post-surgical pain in cardiac surgery
Opioid consumption during surgery and within 72 hours after surgery will be captured
Association between psychological risk factors and chronic post-surgical pain
Time Frame: Hospital Anxiety and Depression Scale will be assessed 1 day before surgery, 3 month postop and 6 month postop
Psychological risk factors assessed using Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale will be assessed 1 day before surgery, 3 month postop and 6 month postop
Association between psychological risk factors and chronic post-surgical pain
Time Frame: EQ-5D questionnaire will be assessed 1 day before surgery, 3 month postop and 6 month postop
Quality of life will be assessed using EQ-5D questionnaire
EQ-5D questionnaire will be assessed 1 day before surgery, 3 month postop and 6 month postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020.446-T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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