Development of Postoperative Pain; Clinical and Genetic Factors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Genetic risk factors for the development of acute pain using a visual analogue scale.
研究概览
简要总结
Pain is the most frequent cause of suffering and disability in society. Despite considerable involvement of genetic factors in pain sensation and sensitivity, the individual genes involved remain largely unidentified.
In this project the investigators will follow patients undergoing elective major surgery for the development of acute and chronic pain. The investigators will search for clinical as well as genetic factors that can predict the development of pain. These can serve as biomarkers to predict acute and chronic pain development and progression in individual patients and help early individual treatment adaptation.
详细描述
Pain is the most frequent cause of suffering and disability in society. Chronic pain seriously impairs quality of life of millions of people worldwide. 10-50% of surgical patients report chronic pain after surgery; up to 10% report severe pain. Thus, chronic pain is a significant medical and financial burden to society.
Despite considerable involvement of genetic factors in pain sensation and sensitivity, individual genes involved remain largely unidentified. Knowledge of genetic factors, their phenotypic expression in pain processing, and their link to neuronal correlates can improve understanding of pain aetiology and processes involved in pain perception and chronification. Also, they can serve as biomarkers to predict chronic pain development and progression in patients and help early individual treatment adaptation.
In this study the investigators will establish a prospective database and biobank of patients undergoing elective major surgery. Using data from the database and biobank, the investigators will identify genetic factors contributing to development of acute and chronic pain after surgery.
Over a period of 10 years the investigators will prospectively include up to 10,000 patients visiting the hospital for elective major surgery. Data defining participants demographics, medical history and questionnaire data will be collected and stored in dedicated databases. Additional details (surgery and perioperative management, pain processing phenotypes and surgical and pain outcomes) will be stored.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Ages 18 - 80 years, consenting, planned surgery, able to understand and answer questionnaires.
排除标准
- •Non-consent, inability to give consent, unplanned and emergency surgery.
结局指标
主要结局
Genetic risk factors for the development of acute pain using a visual analogue scale.
时间窗: 7 days
All patients will be followed for 1 year after elective surgery, during this period the investigators will collect acute pain measures using a visual analogue scale (ranging from 0 (no pain) -10 (pain)) before the operation and 1, 2, 3 and 7 days after the operation.
Genetic risk factors for the development of chronic pain (defined as pain (yes or no) for more than 3 months in one specific body area).
时间窗: 6 months
All patients will be followed for 1 year after elective surgery, during this period the investigators will collect chronic pain measures using a questionnaire before the operation and 1 week, 3 months and 6 months. Chronic pain is defined as pain at a specific body side (yes/no) for more than 3 months.
次要结局
- If the pain influences daily functioning will be assesed with the pain disability index.(6 months)
- Is fear before an operation related to the development of acute and chronic pain after the operation.(once pre-operatively)
- Is the Pain Catastrophizing Scale related to the development of acute and chronic pain after the operation.(once pre-operatively)
- Is days in hospital after the operation associated with pain development.(6 months)
- Is the size of the incision made during the operation associated with pain development.(6 months)
- Is Pain Sensitivity related to the development of acute and chronic pain after the operation.(once pre-operatively)
- Is medication use after the operation assocaited with pain development.(6 months)