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NCT05078398 · ClinicalTrials.gov registry record · NA
Postoperative Opt-In Narcotics Treatment in Breast
A NA study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 109
- Enrollment target
NCT05078398 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 109 participants.
The verdict
NCT05078398, a NA study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 109 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Usual care
- BEHAVIORAL POINT Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2025-01-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05078398
The ClinicalTrials.gov registry entry for NCT05078398 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual care is the first listed.
NCT05078398 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05078398 about?
NCT05078398 is a clinical study titled "Postoperative Opt-In Narcotics Treatment in Breast". 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...
What is the current status of trial NCT05078398?
This trial is currently completed. It is a NA study. The enrollment target is 109 participants. The study started on 2022-06-01. Estimated completion is 2025-01-01.
What interventions are being tested in trial NCT05078398?
The interventions under investigation include: Usual care (BEHAVIORAL), POINT Protocol (BEHAVIORAL).
Who is sponsoring clinical trial NCT05078398?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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