Clinical Prediction Model and External Validation of Chronic Postsurgical Pain in Elders: Retrospective Analysis of A Multi-Center Prospective Database in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,770
- 试验地点
- 1
- 主要终点
- The Brief Pain Inventory-short form
研究概览
简要总结
This study will collect perioperative pain-related data of elderly patients in multi-centers. Analyzing these collected data to find the high-risk factors of chronic postsurgical pain in elderly patients and to establish an early-warning models of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning.
Based on the database, the investigators intend to explore:
- Perioperative risk assessment methods and early warning models for elderly patients;
- Practical, safe, and effective risk prevention and control system through subsequent studies.
详细描述
This study will collect perioperative pain-related data of elderly patients in multi-centers, including: preoperative general data, intraoperative anesthesia and surgical data, clinical laboratory data, postoperative pain and intervention, postoperative complications and quality of life. Analyzing these collected data to find the high-risk factors of chronic postsurgical pain in elderly patients and to establish an early-warning model of chronic postsurgical pain in elderly patients, so as to improve the ability of assessing the risks of chronic postsurgical pain in elderly patients and providing an early warning.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Chronic postsurgical pain (CPSP) CPSP was made based on the guidelines of the International Society for Pain (CPSP: ICD-11) as follows: Chronic postsurgical pain is chronic pain developing or increasing in intensity after a surgical procedure and persisting beyond the healing process, i.e. at least 3 months after surgery. The pain is either localised to the surgical field, projected to the innervation territory of a nerve situated in this area, or referred to a dermatome (after surgery/injury to deep somatic or visceral tissues). Other causes of pain including infection, malignancy etc. need to be excluded as well as pain continuing from a pre-existing pain problem. Dependent on type of surgery, chronic postsurgical pain often may be neuropathic pain.
- •Geriatric surgical patients ≥65 years old
排除标准
- •Patients in the central nervous system group were excluded from cardiac and neurosurgery, patients in the heart injury group were excluded from cardiac surgery, and patients who did not agree to participate in the study were excluded in all groups.
结局指标
主要结局
The Brief Pain Inventory-short form
时间窗: Up to 3 months postoperation
It measured pain location in the body; pain intensity on an 11-point numerical rating scale (NRS; 0 represents "no pain" and 10 the "worst pain imaginable"); analgesic intake; perception of analgesic relief; and pain interference with daily life on an 11-point NRS (0 "does not interfere and 10"completely interferes") indistinct dimensions (general activity, mood, walking, work, relations with others, sleep, and enjoyment of life). Higher scores represent higher levels of pain interference.
Pain trajectories after surgery (Numerical Rating Scale)
时间窗: Up to 3 months postoperation
Pain intensity was assessed using a numerical rating scale (NRS) from 0 to 10, with zero representing no pain and 10 representing worst imaginable pain. The worst pain intensity was then categorized into two groups: no or mild pain (NRS from 0 to 3) and moderate to severe pain (NRS from 4 to 10).
次要结局
- Pain Catastrophizing Scale(within 30 days prior to surgery)
- Complications within 30 days after surgery(Up to 3 months postoperation)
- Postoperative duration of stay in hospital(Up to 3 months postoperation)
- FRAIL Scale(within 30 days prior to surgery ,Up to 3 months postoperation)
- The trajectories of health related quality of life(HRQoL)(within 30 days prior to surgery , 1, 3, 7, 30, 90 days postoperation)
- The Hospital Anxiety and Depression Scale(within 30 days prior to surgery , Up to 3 months postoperation)
研究者
Yanhong Liu
Deputy Chief of administration, Anesthesiology
Chinese PLA General Hospital