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

5 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

1000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Belgio
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgio, 3000
        • Reclutamento
        • University Hospital Leuven
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Chirurgia cardiaca

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of chronic post surgical pain
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Chronic post surgical pain
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2026

Completamento primario (Stimato)

31 agosto 2027

Completamento dello studio (Stimato)

31 maggio 2028

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • S71308

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

Following publication of the manuscript for 5 years

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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