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

NCT07640646 | Recruiting

• 1 other identifier: S71308
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Postoperative Pain; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Chronic post surgical pain

  1 year

• Brief pain inventory (BPI)

  3 months

• Quality of life 5-level EQ-5D version (EQ-5D-5L)

  3 months

• Brief pain inventory (BPI)

  1 year

• Quality of life 5-level EQ-5D version (EQ-5D-5L)

  1 year

Study Arms (1)

Cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Deceased
• Refusal
• Chronic pain in the surgical region

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospital Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Danny Hoogma F Hoogma, MD, PhD

CONTACT

003216344270; danny.hoogma@uzleuven.be

Christel Huygens Huygens

CONTACT

003216344620; christel.huygens@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following publication of the manuscript for 5 years
• Access Criteria: Researchers will be granted access upon presenting a approved study plan and signed data transfer agreement.

Locations

BE (1)