Postoperative Opt-In Narcotics Treatment in Breast

Breast Cancer Clinical Trial

— POINT-B  

Official title:

Postoperative Opt-In Narcotics Treatment in Breast

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078398
• Other study ID #: IRB#21-001169
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: September 2023
• Source: University of California, Los Angeles
• Contact: James Wu, MD
• Phone: (310) 267-7838
• Email: jameswu[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Surgery
• Opioid Use

Intervention

Behavioral:
• POINT Protocol
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.
• Usual care
Will prescribe standardized amount of opioid for postoperative pain without patient input

Locations

Country	Name	City	State
United States	UCLA Ronald Reagan Medical Center	Los Angeles	California
United States	UCLA Santa Monica Medical Center	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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