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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03022864
Other study ID # MRI20161121
Secondary ID
Status Enrolling by invitation
Phase N/A
First received January 8, 2017
Last updated January 17, 2017
Start date October 2016
Est. completion date February 2018

Study information

Verified date January 2017
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date February 2018
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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