Cardiac Surgery, the Incidence and Impact of Chronic postOperative Pain: a Survey (Cardiac COPS)
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Danny Hoogma F Hoogma, MD, PhD
- 电话号码:003216344270
- 邮箱:danny.hoogma@uzleuven.be
研究联系人备份
- 姓名:Christel Huygens Huygens
- 电话号码:003216344620
- 邮箱:christel.huygens@uzleuven.be
学习地点
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Vlaams Brabant
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Leuven、Vlaams Brabant、比利时、3000
- 招聘中
- University Hospital Leuven
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接触:
- Danny Hoogma F Hoogma, MD, PhD
- 电话号码:003216344270
- 邮箱:danny.hoogma@uzleuven.be
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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心脏外科
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of chronic post surgical pain
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Chronic post surgical pain
大体时间: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)
大体时间: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)
大体时间: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)
大体时间:1 year
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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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1 year
|
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Quality of life 5-level EQ-5D version (EQ-5D-5L)
大体时间:1 year
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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 values (-0.59) representing health status 'worse than dead'. |
1 year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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