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临床试验/NCT05473728
NCT05473728已完成不适用

A Nationwide Multi-center Epidemiology Study and Risk Factor Analysis on Chronic Post-surgical Pain After Video-assisted Thoracic Surgery

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 886 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
886
试验地点
1
主要终点
post-surgical pain-6 month

研究概览

简要总结

This study is a nationwide multi-center study to investigate the incidence and risk factors of chronic post-surgical pain (CPSP) after receiving video-assisted thoracic surgery (VATS). Patients receiving VATS in participating centers across China in Aug. 2022 will be assessed for eligibility, and all the enrolled patients will be followed up for at least 6 months. The study's primary outcome is the incidence of CPSP 6 months after VATS. Baseline demographic, psychological , surgical, anesthesia-related and pain-related characteristics will be evaluated for possible risk factors of CPSP after VATS.

详细描述

Study Overview This is a multi-center perspective cohort study on the incidence and risk factors of CPSP after VATS.

Study aims

  1. Investigate the incidence of chronic post-surgical pain in Chinese population who received video-assisted thoracic surgery by carrying out a multi-center, perspective cohort study
  2. Perform regression analysis to evaluate the risk factors for chronic post-surgical pain in video-assisted thoracoscopic surgery.
  3. Establish a risk-prediction model for CPSP after VATS

Time frame:

We plan to recruit patients from Aug 1st, 2022 to Sept 1st, 2022. And our follow-up will be performed at 1 month, 3 months and 6 months after the surgeries. After completing the follow-up of all patients, we are going to build a risk-prediction model and have it validated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • In-patients at participating medical centers
  • Scheduled for unilateral VATS during the study enrollment period

排除标准

  • Emergency surgeries
  • Patients with known pain sensory impairment
  • Patients cannot express themselves so that an NRS score cannot be measured

结局指标

主要结局

post-surgical pain-6 month

时间窗: 6 month after the VATS

Asking patients about the existence of chronic pain related to surgery by telephone interview

次要结局

  • post-surgical pain-3 month(3 month after the VATS)
  • Influence on quality of life(3\6 month after the VATS)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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