Study of Lipid Mediators in Chronic Postoperative Pain Following Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This interventional prospective study aims firstly to investigate variations in lipid levels in blood samples and their potential relationship with the duration and/or intensity of post-operative pain. Secondly, it aims to investigate the activation of peripheral blood mononuclear cells and neutrophils in patient blood samples. The study will enrol women aged 18 years or older who have been newly diagnosed with primary invasive or non-invasive breast cancer requiring surgical removal of the tumour, with or without axillary surgery.
The main objectives of the study are To assess whether there is an association between circulating levels of lipid mediators and chronicity (> 3 months) of postoperative pain after breast cancer surgery.
To assess whether circulating levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.
To assess the existence of an association between resected tissue levels of lipid mediators and chronicity of postoperative pain in breast cancer surgery.
To assess whether tissue levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women older than 18 years
- •Newly diagnosed primary invasive or non-invasive breast cancer, requiring surgical excision of the tumor, with or without axillary surgery
- •Able to give informed consent
排除标准
- •Women aged less than 18 years
- •Pregnant women
- •History of major psychiatric disorders
- •Previous breast or axillary surgery, recurrent disease or detectable metastatic disease at the time of diagnosis
- •Unable to give informed consent
研究组 & 干预措施
Chronic pain
干预措施: Blood sample + questionnaire (Other)
No chronic pain
干预措施: Blood sample + questionnaire (Other)
结局指标
主要结局
Pain intensity
时间窗: Throughout the study, an average of 2 years
Pain intensity will be evaluated using a standardized questionnaire completed by participants at each medical consultation.
Pain duration
时间窗: Throughout the study, an average of 2 years
Pain duration will be evaluated using a standardized questionnaire completed by participants at each medical consultation.
Lipid Mediator Levels in Blood
时间窗: Throughout the study, an average of 2 years
Lipid mediator levels will be quantified in blood samples by LC-MS methods
次要结局
未报告次要终点