Clinical trial NCT03022864: Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI
Official title: Establishment of Accurate Diagnosis and Treatment System for Postoperative Chronic Pain Based on Functional Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Mammary Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: people who undergo selective operation of mastectomy with or without axillary lymph node dissection in ambulatory operation room of Shanghai RenJi Hospital （East part ) during year 2016 to 2018

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.

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

Primary outcomes:
measure: different fMRI results of specific brain regions between people with and without chronic pain
timeFrame: in the first week after surgery
Secondary outcomes:
measure: the incidence of chronic pain after mastectomy
timeFrame: six months after surgery
measure: the quality of life in patients after mastectomy
timeFrame: six months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Weifeng Yu, Doctor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.