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临床试验/NCT03363672
NCT03363672Unknown不适用

Evaluation of the Prevalence and Impact of Chronic Postoperative Pain and Risk Factor Analysis: a Multi-center Prospective Cohort Study

Peking Union Medical College Hospital0 个研究点目标入组 500 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
主要终点
The prevalence of chronic postoperative pain

研究概览

简要总结

Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem, which could last for more than 3 months after surgery. The aim of present study was to assess the prevalence of CPP, investigate its impact on life quality and explore its potential risk factors. After informed consent was signed, patients receiving surgery under general anesthesia in Peking Union Medical College Hospital and other medical centers participating in this study during 2018 will be included. Patients' preoperative information will be collected from medical record, including basic demographic data, primary disease and previous chronic diseases. Intraoperative information will be obtained from anesthesia record, including surgical scope, duration, length and location of incisions and blood loss. Acute pain will be evaluated in the ward of the department of surgery, when an app will be installed on patients' mobile phones. Our long-term postoperative follow-up would be performed by sending out survey questionnaires via this app in the 4th, 8th, 16th, 32th, and 48th weeks after surgery. The survey covers questions regarding the intensity, characteristic, location and impact on daily activities of CPP. Information regarding treatment of CPP will also be collected, if any. All the data gained will be summarized in our database and analyzed.

详细描述

Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem, which could persist beyond wound healing phase and last for more than 3 months after surgery. The prevalence of CPP after sternotomy is estimated to be as high as 14%-61%, according to several recent studies. However, CPP following other types of surgeries has not been well evaluated. There is paucity of literature regarding the impact of CPP on daily life as well. Additionally, the identification of predisposing factors for CPP would provide clues for its prevention and treatment. The aim of present study was to assess the prevalence of CPP, investigate its impact on life quality and explore its potential risk factors.

After informed consent was signed, patients receiving surgery under general anesthesia during 2018 will be included. The sample size in Peking Union Medical College Hospital is estimated to be approximately 700. Furthermore, we are trying to contact with other large hospitals in China to make a multi-center study.

Patients' preoperative information will be collected from medical record, including basic demographic data, primary disease (tumor size, location and peripheral invasion) and previous chronic diseases (hypertension, diabetes, coronary heart disease, chronic kidney disease, anxiety and depression). Intraoperative information will be obtained from anesthesia record, including surgical scope, duration, length and location of incisions and blood loss. Postoperative pain control methods can be learned from medical orders. Acute pain will be evaluated in the ward of the department of surgery before discharge. At the same time, an app will be installed on patients' mobile phones. Our long-term postoperative follow-up would be performed by sending out survey questionnaires via this app in the 4th, 8th, 16th, 32th, and 48th weeks after surgery. The survey covers questions regarding the intensity (Wong-Baker FACES Pain Rating Scale), characteristic, location and impact on daily activities (Brief Pain Index, BPI) of CPP. Furthermore, information regarding treatment of CPP will also be collected, if any. All the data obtained from app could be included into our database and statistically analyzed.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving surgery under general anesthesia during 2018 in Peking Union Medical College Hospital and other medical centers participating in this study.
  • Aged 18-70 years.

排除标准

  • Previous surgery history;
  • Preoperative chronic pain history;
  • Have no access to mobile phone or website;
  • Postoperative chronic infection;
  • Non-radical incision of tumor or malignancy recurrence during follow-up;

结局指标

主要结局

The prevalence of chronic postoperative pain

时间窗: 24 weeks postoperatively

The prevalence of chronic postoperative pain reported by the included patients in the questionnaire issued by app

次要结局

  • The prevalence of chronic postoperative pain(4,8,12,16,20,32,40,48 weeks postoperatively)
  • Wong-Baker Faces Pain Rating Scale(4,8,12,16,20,24,32,40,48 weeks postoperatively)
  • Characteristics and location of chronic postoperative pain(4,8,12,16,20,24,32,40,48 weeks postoperatively)
  • Brief Pain Index(4,8,12,16,20,24,32,40,48 weeks postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang YuGuang

Chairman of anesthesisology department

Peking Union Medical College Hospital

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