Genetic Variants and Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Pain related impairment after surgery and its association to genetic and non-genetic variables
研究概览
简要总结
Prospective observational study to analyse patients' pain related outcome after surgery and ist association to genetic variants and non-genetic variables.
详细描述
Background
Severe acute pain as well as long-lasting pain after surgery and pain-related interference of daily activities are frequent. Some risk factors for severe pain after surgery in adults have been described, e.g. younger age and pre-existing chronic pain. The question arises whether a specific genetic background is related to an unfavorable pain outcome.
Objective
The aim of this study is to investigate clinical and genetic variables and their possible association to severe acute postoperative pain, higher analgesic consumption and the development of chronic postsurgical pain.
Methods
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
- •18 years and older
- •Written informed consent
- •Elective surgery
- •Patients' ability to understand the purpose of the study
排除标准
- •No informed consent
- •Cognitive impairment
研究组 & 干预措施
All patients
Patients undergoing elective surgery with anesthesia
结局指标
主要结局
Pain related impairment after surgery and its association to genetic and non-genetic variables
时间窗: day of surgery up to 1 year after surgery
Measured by the International Pain Outcomes Questionnaire, the Brief Pain Inventory (BPI): Numeric rating scale for pain intensities, affective and physical interference; Composite score = pain interference total scores (PITS scale 0-10) resulting in no interference (PITS=0), mild interference (PITS \>0 and \<2), moderate interference (PITS 2-5) and severe interference (PITS \>5)
次要结局
- Association of genetic and non-genetic variables with analgesic consumption(day of surgery up to one year after surgery)
- Association of genetic and non-genetic variables with pain related outcome of patients 1 year after surgery(Up to one year after surgery)
- Association of genetic and non-genetic variables with chronic neuropathic postsurgical pain(up to one year after surgery)