Cardiac DiseaseNCT04644666
Incidence and Risk Factors for Persistent Post-sternotomy Pain After Cardiac Surgery in Local Chinese Population: a Prospective Cohort Study
An observational study of Cardiac Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- How many people
- 220 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2020to 1 Dec 2030
- 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: Local Chinese population age 18 or older undergoing elective open heart surgery
Who may be able to join
- Adult patients aged 18 or older
- Elective surgery
- Primary isolated coronary artery bypass grafting, aortic valve repair/replacement or combined coronary artery bypass/valve procedure via sternotomy for the first time
Who cannot join
- Emergency surgery
- Redo surgery
- History of thoracotomy or mastectomy
- History of psychosis or illicit drug use
- Estimated glomerular filtration rate (eGFR) <30ml/min or on renal replacement therapy. This is calculated using Cockcroft-Gault formula
- Intraoperative use of remifentanil
- Unable to provide informed consent and complete the questionnaires because of physical or mental incapacity
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Cardiac Disease
- Medical subject headings
- Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic post-sternotomy pain in number
Number of recruited patients who have chronic pain
Measured: 3 months after surgery
Incidence of chronic post-sternotomy pain in percentage
Percentage of recruited patients who have chronic pain
Measured: 3 months after surgery
Incidence of chronic post-sternotomy pain
Number of recruited patients who have chronic pain
Measured: 6 months after surgery
Incidence of chronic post-sternotomy pain
Percentage of recruited patients who have chronic pain
Measured: 6 months after surgery
Secondary outcomes (4)
Association between the severity of acute postoperative pain (measured using visual analogue scale) and the presence of chronic post-surgical pain
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.
Measured: 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
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
Measured: Opioid consumption during surgery and within 72 hours after surgery will be captured
Association between psychological risk factors and chronic post-surgical pain
Psychological risk factors assessed using Hospital Anxiety and Depression Scale
Measured: 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
Quality of life will be assessed using EQ-5D questionnaire
Measured: EQ-5D questionnaire will be assessed 1 day before surgery, 3 month postop and 6 month postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Dec 2020
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Why it stopped: No manpower and funding for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WONG MAN KIN, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644666
- Sponsor's protocol ID
- 2020.446-T
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors for Persistent Post-sternotomy Pain After Cardiac Surgery in Local Chinese Population: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04644666
- Acronym / sponsor ID
- 2020.446-T
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: No manpower and funding for the study.
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 25 Nov 2020 (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.
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.
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 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
- Local Chinese population age 18 or older undergoing elective open heart surgery
Key inclusion criteria (3 listed)
- Adult patients aged 18 or older
- Elective surgery
- Primary isolated coronary artery bypass grafting, aortic valve repair/replacement or combined coronary artery bypass/valve procedure via sternotomy for the first time
Key exclusion criteria (7 listed)
- Emergency surgery
- Redo surgery
- History of thoracotomy or mastectomy
- History of psychosis or illicit drug use
- Estimated glomerular filtration rate (eGFR) <30ml/min or on renal replacement therapy. This is calculated using Cockcroft-Gault formula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of chronic post-sternotomy pain in number
Time frame: 3 months after surgery
Number of recruited patients who have chronic pain
Incidence of chronic post-sternotomy pain in percentage
Time frame: 3 months after surgery
Percentage of recruited patients who have chronic pain
Incidence of chronic post-sternotomy pain
Time frame: 6 months after surgery
Number of recruited patients who have chronic pain
Incidence of chronic post-sternotomy pain
Time frame: 6 months after surgery
Percentage of recruited patients who have chronic pain
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 7 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: paused, as of the sponsor's last update on 22 Oct 2026. 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 Hong Kong. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chronic post-sternotomy pain in number (time frame: 3 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.