Prevalence and Risk Factors for Chronic Post-Surgical Pain Following Video-Assisted Thoracic Surgery : The EVATHO Prospective Bicentric Cohort Study. (EVATHO)
2026年6月29日 更新者：University Hospital, Montpellier
Study of the Prevalence of Chronic Postoperative Pain After Video-Assisted Thoracic Surgery: A Bicentric Cohort Study
Chronic post-surgical pain (CPSP) remains a common complication after thoracic surgery and may significantly impair patients' quality of life. Although the widespread adoption of video-assisted thoracic surgery (VATS) has reduced surgical trauma and improved postoperative recovery, a substantial proportion of patients still develop persistent pain.
The EVATHO study is a multicenter prospective observational cohort designed to determine the prevalence of CPSP three months after VATS and to identify perioperative factors associated with its development. Adult patients undergoing thoracic surgery by VATS at Montpellier and Nice University Hospitals will be prospectively enrolled.
Pain intensity, neuropathic pain characteristics, anxiety, depression, quality of life, and analgesic consumption will be assessed using validated questionnaires during the perioperative period and at 1 and 3 months after surgery. The results of this study may help identify patients at increased risk of CPSP and improve perioperative pain management strategies following thoracic surgery.
研究概览
地位
尚未招聘
研究类型
观察性的
注册 (估计的)
400
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Benjamin Bourdois, MD
- 电话号码：+33467335958
- 邮箱：b-bourdois@chu-montpellier.fr
研究联系人备份
- 姓名：Sophie Bringuier, MD
- 电话号码：+33467335958
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Adult patients undergoing video-assisted thoracic surgery (VATS) for pulmonary resection, pleural procedures, chest wall surgery, or lung biopsy at Montpellier and Nice University Hospitals.
描述
Inclusion Criteria:
- Adult patients undergoing video-assisted thoracic surgery (VATS) for thoracic surgery
Exclusion Criteria:
- Age <18 years
- Adults under legal protection or unable to provide informed non-opposition
- Patients unable to understand or complete the study questionnaires
- Patients not affiliated with a French health insurance scheme.
- Adults under legal protection, including judicial safeguard, guardianship, or curatorship.
- Participation in another clinical study involving an ongoing exclusion period.
- Pregnant or breastfeeding women.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
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 |
|---|---|---|
|
Number of participants with chronic post-surgical pain
大体时间：3 months after surgery.
|
Chronic post-surgical pain defined as a Brief Pain Inventory (BPI) average pain score greater than 3 at the 3-month postoperative follow-up.
|
3 months after surgery.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative pain at 1 month after VATS
大体时间：1 month after thoracic surgery
|
Post-surgical pain defined as a Brief Pain Inventory (BPI) average pain score greater than 3 at the 1-month postoperative follow-up.
|
1 month after thoracic surgery
|
|
Visual Analogue Scale (VAS) pain score
大体时间：Preoperative assessment, postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.
|
Pain intensity measured using the Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
|
Preoperative assessment, postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.
|
|
Cumulative postoperative opioid consumption.
大体时间：Postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.
|
Total opioid consumption during the postoperative period as morphine milligram equivalents
|
Postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.
|
|
Douleur Neuropathie 4 (DN4) score
大体时间：Preoperative assessment, postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.
|
Neuropathic pain measured using the Douleur Neuropathique 4 (DN4) questionnaire.
Scores range from 0 to 10, with scores greater than or equal to 4 indicating neuropathic pain.
|
Preoperative assessment, postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.
|
|
Hospitalier Anxiety and depression Scale (HADS) anxiety score
大体时间：Preoperative assessment, 1 month, and 3 months after surgery.
|
Anxiety measured using the hospital Anxiety and Depression Scale (HADS-A).
Scores range from 0 to 21, with scores greater than or equal to 11 indicating clinically significant anxiety.
|
Preoperative assessment, 1 month, and 3 months after surgery.
|
|
Hospital Anxiety and Depression Scale (HADS) depression score
大体时间：Preoperative assessment, 1 month, and 3 months after surgery
|
Depression measured using the Hospital Anxiety and Depression Scale (HADS-D).
Scores range from 0 to 21, with scores greater than or equal to 11 indicating clinically significant depression.
|
Preoperative assessment, 1 month, and 3 months after surgery
|
|
Brief Pain Inventory (BPI) pain interference score
大体时间：1 month and 3 months after surgery.
|
Pain interference with daily activities measured using the Brief Pain Inventory (BPI) interference subscale
|
1 month and 3 months after surgery.
|
|
Short Form-12 Physical component summary score
大体时间：Preoperative assessment, 1 month, and 3 months after surgery.
|
Physical health-related quality of life measured using the Physical Component Summary (PCS) score of the Short Form-12 (SF-12) questionnaire.
|
Preoperative assessment, 1 month, and 3 months after surgery.
|
|
Short form-12 Mental Component Summary score
大体时间：Preoperative assessment, 1 month and 3 months after surgery
|
Mental health-related quality of life measured using the Mental Component Summary (MCS) score of the Short Form-12 (SF-12) questionnaire.
|
Preoperative assessment, 1 month and 3 months after surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2028年4月1日
研究完成 (估计的)
2028年8月1日
研究注册日期
首次提交
2026年6月21日
首先提交符合 QC 标准的
2026年6月29日
首次发布 (实际的)
2026年7月7日
研究记录更新
最后更新发布 (实际的)
2026年7月7日
上次提交的符合 QC 标准的更新
2026年6月29日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.