Predicting Chronic Pain Following Breast Surgery

NCT04967352 | Unknown

• 1 other identifier: 201610
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Persistent opioid use after 90 days

  continual use of opioids after 90 days following surgery

  90 days

• Persistent pain after 90 days

  persistent surgical pain after 90 days following surgery

  90 days

Secondary Outcomes (6)

• Persistent opioid use after 30 days

  30 days

• Persistent pain after 30 days

  30 days

• Persistent opioid use after 6 months

  6 months

• Persistent pain after 6 months

  6 months

• Acute opioid use

  3 days

Study Arms (2)

Developed Persistent Opioid Use after 3 months following surgery

Did not develop persistent opioid use after 3 months following surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical patients undergoing major breast surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will collect buccal swab specimens from patients for pharmacogenomic screening

MeSH Terms

Conditions

Chronic Pain; Mastodynia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Rodney A Gabriel, MD, MAS

CONTACT

858-663-7747; ragabriel@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 19, 2021
• Study Start: July 19, 2021
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)