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

5 de junio de 2026 actualizado por: Universitaire Ziekenhuizen KU Leuven
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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

1000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Danny Hoogma F Hoogma, MD, PhD
  • Número de teléfono: 003216344270
  • Correo electrónico: danny.hoogma@uzleuven.be

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Bélgica
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Bélgica, 3000
        • Reclutamiento
        • University Hospital Leuven
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra de probabilidad

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Cirugía cardíaca

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of chronic post surgical pain
Periodo de tiempo: 3 months
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Chronic post surgical pain
Periodo de tiempo: 1 year
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)
Periodo de tiempo: 3 months
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)
Periodo de tiempo: 3 months

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)
Periodo de tiempo: 1 year
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)
Periodo de tiempo: 1 year

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Universitaire Ziekenhuizen KU Leuven

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2026

Finalización primaria (Estimado)

31 de agosto de 2027

Finalización del estudio (Estimado)

31 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

1 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de junio de 2026

Publicado por primera vez (Actual)

11 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • S71308

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

Following publication of the manuscript for 5 years

Criterios de acceso compartido de IPD

Researchers will be granted access upon presenting a approved study plan and signed data transfer agreement.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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