Clinical Prediction of Post-surgical Pain: External Validation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 748
- 试验地点
- 2
- 主要终点
- Moderate-to-severe acute post-surgical pain
研究概览
简要总结
This study aims to externally validate two clinical prediction models for moderate-to-severe acute post-surgical pain and chronic post-surgical pain. This multi-centre, prospective cohort study will be conducted in Denmark and will include adult patients undergoing various types of elective or sub-acute surgical procedures.
详细描述
Based on sample size calculations for prediction model validation, a total of 482 patients are required validation of the acute post-surgical pain model and 748 (575 + 30% for loss to follow-up) patients are required for validation of the chronic post-surgical pain model. Therefore, we will aim to recruit 748 patients in total.
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
- •All patients ≥ 18 years undergoing elective or sub-acute surgery
排除标准
- •Cognitive impairment not allowing for informed consent
结局指标
主要结局
Moderate-to-severe acute post-surgical pain
时间窗: First 3 postoperative hours or until discharge from the PACU
Worst pain intensity score at rest ≥ 4 on an 11-point numeric rating scale (NRS; 0-10) in the post-anaesthesia care unit (PACU) following surgery, where 0=no pain and 10=worst pain imaginable.
Chronic post-surgical pain
时间窗: 3 months post-surgery
Pain related to the surgical procedure measured as average pain intensity on rest or movement ≥ 3 in the past one week using an 11-point numeric rating scale (NRS; 0-10) where 0=no pain and 10=worst pain imaginable and average pain interference ≥ 3 using 11-point NRS among any one of seven short-form Brief Pain Inventory items (general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, enjoyment of life) in the past one week, where 0=pain does not interfere and 10=pain completely interferes.
次要结局
- Severe acute post-surgical pain(First 3 postoperative hours or until discharge from the PACU)
研究者
Camilla Gaarsdal Uhrbrand
MD, PhD-fellow
Aarhus University Hospital