NCT03022864

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

January 8, 2017

Last Update Submit

January 17, 2017

Conditions

Chronic PainMammary Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • the incidence of chronic pain after mastectomy

    six months after surgery

  • the quality of life in patients after mastectomy

    six months after surgery

Study Arms (2)

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 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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.

    PMID: 15979027BACKGROUND

  • 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.

    PMID: 24221918BACKGROUND

  • 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.

    PMID: 20399736BACKGROUND

MeSH Terms

Conditions

Chronic PainBreast Neoplasms

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Weifeng Yu, Doctor

    RenJi Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2017

First Posted

January 18, 2017

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

February 1, 2018

Last Updated

January 18, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share