Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Pain | — | UNRESOLVED | — |
| Chronic Pain | — | UNRESOLVED | — |
| Opioid Use | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Developed Persistent Opioid Use after 3 months following surgery
- label
- Did not develop persistent opioid use after 3 months following surgery
Primary outcomes (2)
- measure
- Persistent opioid use after 90 days
- timeFrame
- 90 days
- description
- continual use of opioids after 90 days following surgery
- measure
- Persistent pain after 90 days
- timeFrame
- 90 days
- description
- persistent surgical pain after 90 days following surgery
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available