Postoperative Opt-In Narcotics Treatment in Breast

NCT05078398 | Completed

• 1 other identifier: IRB#21-001169
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 2

Brief Summary

In a recent study, researchers let patients choose what medications to go home with after endocrine surgery. This has not been done in outpatient breast surgery, though several institutions have moved towards avoiding opioids altogether after breast surgery. These institutions only prescribed rescue opioids upon request. The aim of this study is to compare a similar "opt-in" protocol for narcotics to usual care (where patients are routinely discharged with opioids) for outpatient breast surgery. This study will be designed as a randomized, controlled trial. When adult patients consent for outpatient breast surgery, the patients will be asked to participate in the study. Patients who are currently using narcotics would be excluded. The investigators would then randomize participants to the "opt-in" protocol versus being provided with a standard opioid prescription after surgery. Patients in the opt-in protocol will be recommended a pain treatment regimen with over-the-counter medications, acetaminophen or ibuprofen. These patients will be reassured that if their pain is uncontrolled after discharge, a narcotic prescription will be called in to their pharmacy if requested. The investigators will assess patient pain scores and medication use in the recovery area using the electronic medical record. The investigators will collect data on patient pain scores and medication use after discharge on a daily basis via phone call or electronically transmitted survey. The investigators will also evaluate patients at the time of their follow-up visits. Any patient phone calls will be routed to study personnel who will fill narcotic prescription requests if requested. Finally, among patients who do receive an opioid prescription, the investigators will track their opioid consumption.

Conditions

Breast Cancer; Breast Surgery; Opioid Use

Outcome Measures

Primary Outcomes (2)

• Daily peak pain scores on an 11-point numeric rating scale [0-10, with 0 indicating no pain and 10 indicating worst pain possible]

  Daily peak pain

  Postoperative day 0-7

• Number of opioid pills dispensed

  Total number of pills, (also to be expressed in morphine equivalents) dispensed on day of surgery as well through the immediate post operative period if refills or a rescue prescription were requested

  Postoperative day 0-7

Secondary Outcomes (2)

• Physical and Mental Health Summary Score from Patient-Reported Outcomes Measurement Information System (PROMIS) Survey (T-score, mean is 50 and 10 is standard deviation)

  Baseline and postoperative day 7

• Amount of opioid pills consumed

  Postoperative day 0-7

Study Arms (2)

POINT-B

EXPERIMENTAL

Patients will receive perioperative counseling on opioid consumption following breast surgery, both preoperatively and postoperatively. Upon discharge, patients will be asked whether they would like to be discharged with narcotic pain medication or not.

Behavioral: POINT Protocol

Usual Care

ACTIVE COMPARATOR

Patients will receive equivalent of 5 tabs of Norco 5/325 mg upon discharge routinely

Behavioral: Usual care

Interventions

POINT Protocol BEHAVIORAL

Patients will receive counseling on risks and benefits of opioids for pain control, asked to choose whether they need opioid prescription when ready for discharge.

POINT-B

Usual care BEHAVIORAL

Will prescribe standardized amount of opioid for postoperative pain without patient input

Usual Care

Eligibility Criteria

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

You may qualify if:

• Undergoing outpatient breast surgery (less than 24 hour stay)
• Understands written English

You may not qualify if:

• Current ongoing opioid use
• Increased complexity of surgery requiring longer hospital stay

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

UCLA Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

UCLA Santa Monica Medical Center

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 14, 2021
• Study Start: June 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (2)