Skip to main content
Clinical Trials/NCT03022864
NCT03022864
Unknown
Not Applicable

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

RenJi Hospital0 sites100 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
RenJi Hospital
Enrollment
100
Primary Endpoint
different fMRI results of specific brain regions between people with and without chronic pain
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
February 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: in the first week after surgery

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

Secondary Outcomes

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

Similar Trials