Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT04967352

Conditions

Chronic Pain

Opioid Use

Breast Pain

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Breast surgery, which includes mastectomy, breast reconstructive surgery, or lumpectomies with sentinel node biopsies, may lead to the development of chronic pain and long-term opioid use. In the era of an opioid crisis, it is important to risk-stratify this surgical population for risk of these outcomes in an effort to personalize pain management. The opioid epidemic in the United States resulted in more than 40,000 deaths in 2016, 40% of which involved prescription opioids. Furthermore, it is estimated that 2 million patients become opioid-dependent after elective, outpatient surgery each year. After major breast surgery, chronic pain has been reported to develop anywhere between 35% - 62% of patients, while about 10% use long-term opioids. Precision medicine is a concept at which medical management is tailored to an individual patient based on a specific patient's characteristics, including social, demographic, medical, genetic, and molecular/cellular data. With a plethora of data specific to millions of patients, the use of artificial intelligence (AI) modalities to analyze big data in order to implement precision medicine is crucial. We propose to prospectively collect rich data from patients undergoing various breast surgeries in order to develop predictive models using AI modalities to predict patients at-risk for chronic pain and opioid use.

Conditions

Chronic Pain

Opioid Use

Breast Pain

Breast Cancer

Study ID

NCT04967352

Start date

Jul 19, 2021

Status verified date

Jul, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Jul 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient undergoing major breast surgery (except for simple lumpectomy)

Exclusion Criteria:

  • refusal to consent
  • lack of independent decision-making capacity
  • inability to communicate effectively with research personnel

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Developed Persistent Opioid Use after 3 months following surgery

Did not develop persistent opioid use after 3 months following surgery

Primary outcome measure

  • Persistent opioid use after 90 days [ Time Frame: 90 days ]
  • Persistent pain after 90 days [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 27, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2023-07-27.