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临床试验/NCT03022864
NCT03022864Unknown不适用

Establishment of Accurate Diagnosis and Treatment System for Postoperative Chronic Pain Based on Functional Magnetic Resonance Imaging

RenJi Hospital0 个研究点目标入组 100 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
different fMRI results of specific brain regions between people with and without chronic pain

研究概览

简要总结

Postoperative pain is an ideal model for study on acute pain changing into chronic pain. The functional imaging of magnetic resonance can reflect the extent and character of pain exactly and the structural imaging of it can be a sign of the change. By analyzing fMRI results of participants with acute pain and following them up for three months, the investigators expect to find objective indicators for acute pain changing into chronic pain and give preventive analgesia for people with high risk of chronic pain.

详细描述

The day before surgery, evaluate and choose patients according to inclusion and exclusion criteria. Use the same anaesthesia and management and record information needed by the case report format. Patients are examined by fMRI on their brains during the first week after surgery. Follow up the patients after surgery for three months to find out whether they have chronic pain. The NRS, DN4, ID pain and QLQ-C30 are used for each patient.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • junior high school degree or above
  • can be communicated in mandarin normally
  • selective operation of mastectomy with or without axillary lymph node dissection
  • similar operation method and incision size
  • BMI between 18 and 30
  • ASA grade I-II;informed consent

排除标准

  • with brain disease or with brain disease history
  • Opioid allergy
  • with claustrophobia
  • with history of chronic pain
  • with psychological or emotional problems
  • Serious hearing or visual impairment
  • those who refuse to participant in this study

结局指标

主要结局

different fMRI results of specific brain regions between people with and without chronic pain

时间窗: in the first week after surgery

amplitude of low frequency fluctuation(ALFF) and regional homogeneity(ReHo) of related brain regions

次要结局

  • the incidence of chronic pain after mastectomy(six months after surgery)
  • the quality of life in patients after mastectomy(six months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

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