NCT07044583 SAVE Trial: SAfe Opioid Use Video Education
| NCT ID | NCT07044583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Breast Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2025-10-27 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study will assess the efficacy of a standardized postoperative patient-centered intervention designed to educate patients on the opioid epidemic, the judicious use of opioids, and the proper disposal of opioids. This trial is a single-institution, randomized controlled trial comparing total post-discharge opioid use in breast reconstruction patients who view an educational video on proper opioid use to patients who do not receive intentional education (the current standard of care). This will be the first project to inform opioid prescribing guidelines for breast reconstruction patients based on actual opioid use data and will describe a patient-centered intervention that is easily incorporated into current postoperative workflows. Broadly, the results of the study aim to set the foundation to incorporate cost-effective educational interventions across multiple surgical specialties that require postoperative opioid prescription.
Eligibility Criteria
Inclusion Criteria: * Female patients 18 years of age or older * Patients undergoing abdominally based autologous free flap breast reconstruction after mastectomy for breast cancer or cancer prophylaxis Exclusion Criteria: * Patients undergoing reoperations such as autologous breast reconstruction as a revision procedure following failed implant-based reconstruction * Patients undergoing multiple procedures such as mastectomy and immediate reconstruction * Patients with documented chronic opioid use prior to procedure, chronic pain condition
Contact & Investigator
Jay Agarwal, MD
PRINCIPAL INVESTIGATOR
Huntsman Cancer Institute
Frequently Asked Questions
Who can join the NCT07044583 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07044583 currently recruiting?
Yes, NCT07044583 is actively recruiting participants. Contact the research team at jay.agarwal@hsc.utah.edu for enrollment information.
Where is the NCT07044583 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT07044583 clinical trial?
NCT07044583 is sponsored by University of Utah. The principal investigator is Jay Agarwal, MD at Huntsman Cancer Institute. The trial plans to enroll 68 participants.