Cardiac Surgery, the Incidence and Impact of Chronic postOperative Pain: a Survey (Cardiac COPS)

This survey study aims to investigate the incidence of Chronic post surgical pain (CPSP) in cardiac surgery patients treated at UZ Leuven. The primary hypothesis is that the incidence of CPSP at 3 months postoperatively is lower than 33%, which is the rate commonly reported in the literature. Secondary objectives include comparing CPSP incidence based on the type of surgical incision, as well as comparing incidences between type of surgery. Finally, the study will assess pain intensity, interference with daily activities, and quality of life of 3 months and when required also at 1 years postoperatively.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Chronic Postoperative Pain

Detailed Description

Chronic postsurgical pain (CPSP) is a significant and under-recognized complication following cardiac surgery, with incidence estimates ranging from 11% to 39% at 6-12 months and persisting in a notable minority for years postoperatively. Recent prospective cohort studies have demonstrated that nearly one in three patients report pain at 3 months, and approximately 15% continue to experience pain at 1 year after cardiac surgery. Long-term follow-up data indicate that up to 10% of patients may have persistentend pain, with substantial impact on health-related quality of life.

Systematic reviews and meta-analyses confirm that CPSP after cardiac surgery is common, with moderate to severe pain intensity reported in up to half of affected patients, and neuropathic pain phenotypes are frequently observed. The chest remains the primary location, but pain may also involve the leg, especially in cases with saphenous vein harvesting. Risk factors consistently identified include younger age, female sex, pre-existing chronic pain, preoperative depression or anxiety, high acute postoperative pain scores, and intraoperative factors such as remifentanil infusion and prolonged operative time.

The Society of Cardiovascular Anesthesiologists, in its recent practice advisories, emphasizes the importance of multimodal analgesia and individualized pain management strategies to mitigate CPSP risk and improve postoperative outcomes. Despite advances in perioperative care, there remains considerable variability in pain management practices and a lack of consensus guidelines, underscoring the urgent need for further research and standardized approaches. Collectively, these findings establish CPSP after cardiac surgery as a clinically relevant problem with substantial patient and healthcare system burden, justifying the need for rigorous investigation into its mechanisms, risk factors, and preventive strategies.

In the UZ Leuven we have standardized our perioperative care and pain management. The alarming incidence of CPSP is not observed in our center, however, this is possibly due to lack of systematic follow-up. The current study aims to bridge this gap and guide future research within our hospital.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Danny Hoogma F Hoogma, MD, PhD; Phone Number: 003216344270; Email: danny.hoogma@uzleuven.be
• Study Contact Backup: Name: Christel Huygens Huygens; Phone Number: 003216344620; Email: christel.huygens@uzleuven.be

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Recruiting
      • University Hospital Leuven
      • Contact: Danny Hoogma F Hoogma, MD, PhD; Phone Number: 003216344270; Email: danny.hoogma@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study will include all adult patients undergoing cardiac surgery over a 1-year period at UZ Leuven, totaling approximately 1200 cases. With an expected response rate of 80%, the final sample size is estimated at 1000 patients. This sample size is considered sufficient to obtain robust estimates of both early and long-term incidence of CPSP following cardiac surgery at UZ Leuven to support future prospective studies.

Description

Inclusion Criteria:

1. Adults, aged ≥ 18 years of age, who underwent cardiac surgery (valvular, coronary bypass, other intracardiac or aortic surgery) during the 1 year recruitment period
2. Able to provide informed consent
3. Able to respond by telephone

Exclusion Criteria:

1. Deceased
2. Refusal
3. Chronic pain in the surgical region

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of chronic post surgical pain	Numerical rating scale (NRS) for pain (persistent or recurrent) longer than 3 months present, the apin began or increased in intensity after surgery, the pain is in the surgical area and persisted for at least 3 months after the initiation event, and is not better accounted for by an infection, malignancy, a pre-existing pain condition or alternative.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic post surgical pain	Numerical rating scale (NRS) for pain (persistent or recurrent) longer than 3 months present, the apin began or increased in intensity after surgery, the pain is in the surgical area and persisted for at least 3 months after the initiation event, and is not better accounted for by an infection, malignancy, a pre-existing pain condition or alternative.	1 year
Brief pain inventory (BPI)	Details from the BPI (short-form) will be evaluated via telephone call during which pain severity score (mean of items worst pain, least pain and current pain) and pain interference score (mean of interference of pain with general activity, mood, walking, work, relations, sleep enjoyment of life) will be assessed. All items will be assessed on a score of 0-10, with 0 being no pain or interference and 10 the worst pain or impact.	3 months
Quality of life 5-level EQ-5D version (EQ-5D-5L)	The EQ-5D-5L evaluates Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. These domains are score on 5 levels (no problem (1) to extreme problem (5), with higher numbers indicating worse health status. A patient rated assessment of they overall health EQ visual analoge score (EQ VAS) with 0 being the worst score up to 100 being the best score. The digits-string of the EQ-5D-5L is converted into a single index value based on the Belgian set to have a country-specific scoring algorithm with max of 1.0, reflecting perfect health, down to negative (-0.59) values representing health status 'worse than dead'.	3 months
Brief pain inventory (BPI)	Details from the BPI (short-form) will be evaluated via telephone call during which pain severity score (mean of items worst pain, least pain and current pain) and pain interference score (mean of interference of pain with general activity, mood, walking, work, relations, sleep enjoyment of life) will be assessed. All items will be assessed on a score of 0-10, with 0 being no pain or interference and 10 the worst pain or impact.	1 year
Quality of life 5-level EQ-5D version (EQ-5D-5L)	The EQ-5D-5L evaluates Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. These domains are score on 5 levels (no problem (1) to extreme problem (5), with higher numbers indicating worse health status. A patient rated assessment of they overall health EQ visual analoge score (EQ VAS) with 0 being the worst score up to 100 being the best score. The digits-string of the EQ-5D-5L is converted into a single index value based on the Belgian set to have a country-specific scoring algorithm with max of 1.0, reflecting perfect health, down to negative values (-0.59) representing health status 'worse than dead'.	1 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: S71308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The trial protocol, statistical analysis plan, de-identified participant data (including data dictionary), statistical code, and additional study materials are available from the corresponding author upon reasonable request danny.hoogma@uzleuven.be.
• IPD Sharing Time Frame: Following publication of the manuscript for 5 years
• IPD Sharing Access Criteria: Researchers will be granted access upon presenting a approved study plan and signed data transfer agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No