Postoperative Opt-In Narcotics Treatment in Breast

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Postoperative Opt-In Narcotics Treatment in Breast

Conditions
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Breast Cancer, Breast Surgery, Opioid Use

Intervention / Treatment
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* Behavioral: POINT Protocol
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POINT-B<br>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<br>* 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.<br>|
| Active Comparator: Usual Care<br>Patients will receive equivalent of 5 tabs of Norco 5/325 mg upon discharge routinely | Behavioral: Usual care<br>* Will prescribe standardized amount of opioid for postoperative pain without patient input<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | PROMIS Quality of life | Baseline and postoperative day 7 |