Predicting Chronic Pain Following Breast Surgery

Development of Predictive Models Using Artificial Intelligence for Postoperative Chronic Pain and Opioid Use Following Breast Surgery: A Prospectively-Designed Study

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Chronic Pain; Opioid Use; Breast Pain

Detailed Description

The primary objective of this is to develop predictive models using artificial intelligence algorithms to predict acute and chronic pain and opioid use in patients undergoing breast surgery. Development of these models will involve prospectively collecting data from this surgical population, including: 1) survey results from the Brief Pain Inventory, Fibromyalgia Survey Criteria, and PROMIS scales (depression scale, anxiety scale, physical function scale, fatigue scale, sleep disturbance scale); 2) pharmacogenomics (single nucleotide peptides from COMT, BDNF, SCN11a, OPRM1, ABCB1, CYPD26, and CYP34A, to name a few); 3) preoperative comorbidities (including but not limited to diabetes mellitus, chronic pain, psychiatric disorders, substance abuse history, obstructive sleep apnea, etc); 4) preoperative labs (i.e. hemoglobin); 5) demographic data (i.e. socioeconomic status, religion, ethnicity; primary language spoken, age, body mass index, sex, etc); 6) preoperative medication use; 7) primary surgical diagnosis; 8) surgery; and 9) social support system. Intraoperative data will include: 1) primary anesthetic type; 2) case duration; 3) total opioid use; 4) non-opioid analgesic use; 5) heart rate hemodynamics; and 6) blood pressure hemodynamics. Postoperative data will include: 1) total opioid use; 2) discharge medications; 3) hospital length of stay; 4) pain scores; 5) postoperative vital signs (blood pressure, heart rate); and 6) participation with physical therapy. The primary outcome measures will be opioid use in the acute period and chronic postoperative stage (30 and 90 days and 6 months) and development of chronic pain (up to 6 months after surgery). The model with the best performance will be used to develop a predictive analytic system aimed to identify high risk opioid patients in order to allocate expert pain management resources to those patients. We hypothesize that we can develop an accurate model for identifying high risk opioid users and patients at-risk for chronic pain in these surgical populations and subsequently implement a predictive analytic system that can detect these patients early-on.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Rodney A Gabriel, MD, MAS; Phone Number: 858-663-7747; Email: ragabriel@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • University of California San Diego
      • Contact: Rodney A Gabriel, MD; Phone Number: 858-663-7747; Email: ragabriel@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Surgical patients undergoing major breast surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Developed Persistent Opioid Use after 3 months following surgery
Did not develop persistent opioid use after 3 months following surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistent opioid use after 30 days	continual use of opioids 30 days after surgery	30 days
Persistent pain after 30 days	persistent surgical pain after 30 days following surgery	30 days
Persistent opioid use after 6 months	continual use of opioids 6 months after surgery	6 months
Persistent pain after 6 months	persistent surgical pain after 6 months following surgery	6 months
Acute opioid use	total opioid use during the first 3 days following surgery	3 days
Acute pain	median pain scores (numeric rating scale) during the first 3 days following surgery	3 days

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Estimated): July 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Mastodynia
• Other Study ID Numbers: 201610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No