Behavioural and Neurophysiological Measurements for the Assessment of Central Sensitisation and Postoperative Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- mechanical pinprick perceived intensity
研究概览
简要总结
One out of 10 patients undergoing surgery develops persistent post-surgical pain (PPSP). Unfortunately, available therapies for treating this pain have limited success. It is therefore of great importance to find strategies to prevent PPSP. The goal of this project is to find new screening tools that identify patients that are at risk for developing PPSP.
Tissue injury and inflammation following surgery increase the excitability of spinal nociceptive neurons ("central sensitisation", CS) with pain hypersensitivity as consequence. It is thought that CS plays an important role in persistent pain.
The first objective of this project is to assess in human patients if the propensity to develop CS manifested as secondary hyperalgesia before surgery is predictive for PPSP.
In addition, we will test if the frequency content of the resting-state EEG reflecting the initial state of the brain will be related to the propensity for developing CS and to the presence of PPSP at two months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for a lateral thoracotomy as treatment for primary lung cancer
- •Ability to provide written informed consent
排除标准
- •Evidence for a clinically-significant alteration of the skin of the volar forearms
- •Pregnancy
- •Having a pacemaker or implanted cardiac defibrillator
结局指标
主要结局
mechanical pinprick perceived intensity
时间窗: 1 day before surgery
magnitude of the increase in sensitivity to mechanical pinprick stimuli after HFS
resting state EEG
时间窗: 1 week before surgery
frequency content of the resting state EEG
area of increased mechanical pinprick sensitivity
时间窗: 1 day before surgery
spatial extent of the increased sensitivity to mechanical pinprick stimuli after HFS
次要结局
未报告次要终点