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Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Mammary Cancer
Chronic Pain

Study type

Observational

Funder types

Other

Identifiers

NCT03022864
MRI20161121

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Chronic pain
Description:
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
Description:
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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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