Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain, Mammary Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic pain<br>Follow up the patients for three months after surgery using the designed table. If the patient evaluate the pain more than 3 points according the Numerical Rating Scale, then it can be considered that the patient has chronic pain. | |
| No chronic pain<br>Follow up the patients for three months after surgery using the designed table. If the patient evaluate the pain no more than 3 points according the Numerical Rating Scale, then it can be considered that the patient doesn't have chronic pain. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of chronic pain after mastectomy | calculate the percentage of participants who rate pain more than three points on numerical rating scale | six months after surgery | 
| the quality of life in patients after mastectomy | 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 | six months after surgery |