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Opt-In Narcotics Protocol for Breast Surgery (POINT-B Trial)

N/A

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative day 0-7

Awards & highlights

POINT-B Trial Summary

This trial will look at the effects of an "opt-in" protocol for narcotics vs. routine prescription of opioids after outpatient breast surgery.

Who is the study for?

This trial is for adults who are having outpatient breast surgery and can understand written English. It's not for those currently using opioids or needing complex surgery with a longer hospital stay.Check my eligibility

What is being tested?

The study compares an 'opt-in' approach, where patients choose if they want narcotics post-surgery, to the usual care of routinely providing opioid prescriptions. Participants will be randomly assigned to one of these two approaches.See study design

What are the potential side effects?

While the trial focuses on reducing opioid use, potential side effects may include pain that might not be fully managed by over-the-counter medications like acetaminophen or ibuprofen.

POINT-B Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative day 0-7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative day 0-7

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative day 0-7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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)

POINT-B Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: POINT-BExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,529 Previous Clinical Trials

10,277,562 Total Patients Enrolled

8 Trials studying Breast Cancer

1,432 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for the participants of this experiment?

"Clinicaltrials.gov data reveals that this medical trial is actively accepting participants and was first made public on the 1st of June 2022, with its details last revised on 20th September 2023."

Answered by AI

How many participants are enrolled in this clinical trial?

"Affirmative. As seen on clinicaltrials.gov, this medical trial is actively searching for participants having initially been posted on June 1st 2022 and recently updated on September 20th 2023. This experiment requires 240 patients to be recruited from two separate locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Postoperative Opt-In Narcotics Treatment in Breast

James Wu, MD 2022. "Postoperative Opt-In Narcotics Treatment in Breast". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05078398.