Study of the Prevalence of Chronic Postoperative Pain After Video-Assisted Thoracic Surgery: A Bicentric Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Number of participants with chronic post-surgical pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients undergoing video-assisted thoracic surgery (VATS) for thoracic surgery
排除标准
- •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.
结局指标
主要结局
Number of participants with chronic post-surgical pain
时间窗: 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.
次要结局
- Postoperative pain at 1 month after VATS(1 month after thoracic surgery)
- Visual Analogue Scale (VAS) pain score(Preoperative assessment, postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.)
- Cumulative postoperative opioid consumption.(Postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.)
- Douleur Neuropathie 4 (DN4) score(Preoperative assessment, postoperative day 1, postoperative day 2, 1 month, and 3 months after surgery.)
- Hospitalier Anxiety and depression Scale (HADS) anxiety score(Preoperative assessment, 1 month, and 3 months after surgery.)
- Hospital Anxiety and Depression Scale (HADS) depression score(Preoperative assessment, 1 month, and 3 months after surgery)
- Brief Pain Inventory (BPI) pain interference score(1 month and 3 months after surgery.)
- Short Form-12 Physical component summary score(Preoperative assessment, 1 month, and 3 months after surgery.)
- Short form-12 Mental Component Summary score(Preoperative assessment, 1 month and 3 months after surgery)