Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI

• Conditions: Chronic Pain; Mammary Cancer

• Registration Number: NCT03022864
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study Start: 2016-10
• Status Verified: 2017-01
• Study First Submitted: 2017-01-08
• Study First Submitted QC: 2017-01-17
• Last Update Submitted: 2017-01-17
• Study First Posted: 2017-01-18
• Last Update Posted: 2017-01-18
• Primary Completion: 2017-11
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
different fMRI results of specific brain regions between people with and without chronic pain	in the first week after surgery	amplitude of low frequency fluctuation(ALFF) and regional homogeneity(ReHo) of related brain regions

Secondary Outcome Measures

Name	Time	Method
the incidence of chronic pain after mastectomy	six months after surgery	calculate the percentage of participants who rate pain more than three points on numerical rating scale
the quality of life in patients after mastectomy	six months after surgery	the results of brief pain inventory in the first week after surgery and the EORTC QLQ-C30 results in the first, second and third month after surgery