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Postoperative Opt-In Narcotics Treatment in Breast (POINT-B)

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status

Enrolling

Conditions

Breast Cancer
Breast Surgery
Opioid Use

Treatments

Behavioral: Usual care
Behavioral: POINT Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT05078398
IRB#21-001169

Details and patient eligibility

About

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.

Full description

Due to the current opioid epidemic, there has been increased focus on the prescribing patterns of physicians and greater incentive to reduce the amount of narcotic pain medication prescribed.

A recent publication in Journal of American Medical Association Surgery conducted by researchers from the same institution found that giving patients the option of choosing to receive a narcotic prescription or not following endocrine surgery significantly reduced opioid prescriptions and waste without increased pain or worse quality of life. No patients called in to request narcotic pain medication after discharge.

Significance:

Given the current health care and political climate, there has been increasing focus on reducing the amount of narcotics prescribed by health care providers. Based on the results of the above cited study, the investigators believe implementing an opt-in program at University of California at Los Angeles will also significantly decrease the amount of opioids prescribed for postoperative pain following outpatient breast surgery as well.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

240 participants in 2 patient groups

POINT-B
Experimental group
Description:
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.
Treatment:
Behavioral: POINT Protocol
Usual Care
Active Comparator group
Description:
Patients will receive equivalent of 5 tabs of Norco 5/325 mg upon discharge routinely
Treatment:
Behavioral: Usual care

Trial contacts and locations

2

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Central trial contact

James Wu, MD

Data sourced from clinicaltrials.gov

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