Cardiac Surgery, the Incidence and Impact of Chronic postOperative Pain: a Survey (Cardiac COPS)
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Danny Hoogma F Hoogma, MD, PhD
- Telefonní číslo: 003216344270
- E-mail: danny.hoogma@uzleuven.be
Studijní záloha kontaktů
- Jméno: Christel Huygens Huygens
- Telefonní číslo: 003216344620
- E-mail: christel.huygens@uzleuven.be
Studijní místa
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Vlaams Brabant
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Leuven, Vlaams Brabant, Belgie, 3000
- Nábor
- University Hospital Leuven
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Kontakt:
- Danny Hoogma F Hoogma, MD, PhD
- Telefonní číslo: 003216344270
- E-mail: danny.hoogma@uzleuven.be
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- Deceased
- Refusal
- Chronic pain in the surgical region
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Operace srdce
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of chronic post surgical pain
Časové okno: 3 months
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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.
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3 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Chronic post surgical pain
Časové okno: 1 year
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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.
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1 year
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Brief pain inventory (BPI)
Časové okno: 3 months
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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.
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3 months
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Quality of life 5-level EQ-5D version (EQ-5D-5L)
Časové okno: 3 months
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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
|
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Brief pain inventory (BPI)
Časové okno: 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
|
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Quality of life 5-level EQ-5D version (EQ-5D-5L)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- S71308
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Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
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