Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI

NCT ID: NCT03022864

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-02-28

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.

Conditions

Chronic Pain; Mammary Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic pain

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 interventions assigned to this group

No chronic pain

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weifeng Yu, Doctor

Role: STUDY_CHAIR

RenJi Hospital

References

Apkarian AV, Bushnell MC, Treede RD, Zubieta JK. Human brain mechanisms of pain perception and regulation in health and disease. Eur J Pain. 2005 Aug;9(4):463-84. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.

Reference Type: BACKGROUND

PMID: 15979027 (View on PubMed)

Bailly F, Maigne JY, Genevay S, Marty M, Gandjbakhch F, Rozenberg S, Foltz V. Inflammatory pain pattern and pain with lumbar extension associated with Modic 1 changes on MRI: a prospective case-control study of 120 patients. Eur Spine J. 2014 Mar;23(3):493-7. doi: 10.1007/s00586-013-3036-6. Epub 2013 Sep 25.

Reference Type: BACKGROUND

PMID: 24221918 (View on PubMed)

Baliki MN, Geha PY, Fields HL, Apkarian AV. Predicting value of pain and analgesia: nucleus accumbens response to noxious stimuli changes in the presence of chronic pain. Neuron. 2010 Apr 15;66(1):149-60. doi: 10.1016/j.neuron.2010.03.002.

Reference Type: BACKGROUND

PMID: 20399736 (View on PubMed)

Other Identifiers

MRI20161121

Identifier Type: -

Identifier Source: org_study_id