DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Neuropathic Pain After Lung Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Chronic Neuropathic Pain, Postoperative
研究概览
简要总结
To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts.
详细描述
Pain and loss of function are intimately associated with the reaction of the nervous system to neural damage. A lesion to the somatosensory nervous system caused by mechanical trauma, metabolic disease, neurotoxic chemicals, infection or tumor invasion may give rise to neuropathic pain. Neuropathic pain affects around 8% of the population and may negatively impact the individual's quality of life; moreover, the condition leads to significant costs to the healthcare system and society. Not all subjects with such a lesion develop neuropathic pain, and those who do develop neuropathic pain have varying degrees of symptom severity, impact and outcomes and may respond unpredictably to treatment.
The interaction between genetics and environmental and clinical factors in a susceptible individual most likely contribute to the variation in pain prevalence and severity. A better understanding of the exact nature of these risk factors and their interactions will ultimately improve the patients' health, both in terms of recognizing patients at risk and identifying new treatment modalities.
Genetic, neurophysiological and psychological factors all influence the risk of developing persistent pain. It is therefore possible to describe a genetic, neurophysiological and psychological profile, in particular in patients experiencing neuropathic pain after surgery and/or neurotoxic chemotherapy.
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
- 否
入选标准
- •Male and female subjects.
- •Age ≥18 years.
- •Patients scheduled for lung cancer resection performed via thoracoscopy and/or thoracotomy, including lobectomy, bilobectomy, pneumonectomy, resection of the tracheobronchial bifurcation, wedge resection, sleeve resection and combinations hereof.
- •Willingness and ability to comply with study procedures as judged by the site investigator/manager.
- •Expected availability for follow-up throughout the study, i.e., ~12 months.
- •Willingness to voluntarily sign and date the study-specific informed consent form.
排除标准
- •Mental incapacity or language barriers precluding adequate understanding of study procedures.
- •Current alcohol or substance abuse according to the site investigator's medical judgement.
- •Unsuitability for participation in the study for any other reason, e.g. due to a significant serious underlying condition (e.g. other cancer or AIDS), as determined by the site investigator/manager.
结局指标
主要结局
Chronic Neuropathic Pain, Postoperative
时间窗: 12 months after surgery
Neuropathic pain grading system, Finnerup et al. 2016 will be used.
次要结局
- Chronic Chemotherapy-induced Peripheral Neuropathy(12 months after surgery)
- Chronic Chemotherapy-induced Neuropathic Pain(12 months after surgery)
- Acute Postoperative Pain(0-5 days after surgery)
- Area of peri-incisional hyperalgesia(0-5 days after surgery)