Chronic Postsurgical Pain: Multivariate Prediction Model
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Chronic Post Surgery Pain (CPSP)
研究概览
简要总结
The goal of this observational study is to identify the risk factors of Chronic Postoperative pain (or Chronic Post Surgery Pain - CPSP) three months after surgery and, subsequently. the development of a risk index to identify high-risk patients considering the multifactorial etiology of CPOP in adult patients undergoing any type of elective surgery.
详细描述
The study aims to identify the risk factors of CPSP three months after surgery and subsequently develop a risk index to identify high-risk patients considering the multifactorial etiology of CPSP.
A comprehensive entry pool was derived from a systematic literature search. Data collection will record parameters at four different time points: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; postoperative period (from the third month after the operation).
The outcome variable is the presence of CPSP assessed 3 months postoperatively and defined as a mean pain intensity of at least 3 on the NRS (one-dimensional pain scale from 0 to 10) over the past three days and pain localized to the field surgical (or to the area of the lesion) projected into the innervation territory of a nerve located in this area, or referred to a dermatome.
Four separate forecasting models will be developed using data derived from surveys carried out at relevant time points for the development of the risk index.
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
- •Adult Patients
- •Patients undergoing any type of elective surgery
排除标准
- •Patients with sensory impairments
- •Patients unable to communicate
- •Patients with cognitive impairments
- •Patients with insufficent knowledge of the language
结局指标
主要结局
Chronic Post Surgery Pain (CPSP)
时间窗: 3 months
Presence of CPSP assessed 3 months after surgery and defined as an average pain intensity of at least 3 points on the NRS scale (one-dimensional pain scale - from 0 to 10 points) in the last three days and pain localized to the surgical field (or in the lesion area) projected into the innervation territory of a nerve located in this area, or referred to a dermatome.
次要结局
- Pre operative factors(60 to 1 day before the scheduled procedure)
- Perioperative factors - before surgery(The day of the scheduled surgery - before the surgery)
- Post operative factors(3 months after surgery)
- Perioperative factors - after surgery(Immediately after the surgery to 48 hours after the surgery)
研究者
Luigi Cardia
Principal Investigator
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva