Video education to promote safe opioid use after breast reconstruction
Official title: SAVE Trial: SAfe Opioid Use Video Education
Run by University of Utah · NCT07044583 · Data updated 2026-11-12
This trial tests whether a short educational video about opioid use and proper disposal reduces post-discharge opioid use in women having abdominally based autologous free-flap breast reconstruction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 68 (estimated) |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | October 27, 2025 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | November 26, 2025 |
| Trial ID | NCT07044583 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult female patients (age 18+) scheduled for abdominally based autologous free-flap breast reconstruction after mastectomy for cancer or prophylaxis, who are not chronic opioid users and are not having revision or multiple concurrent procedures, are ideal candidates.
✕Probably not a fit
Patients with documented chronic opioid use before surgery, those undergoing revision reconstruction or multiple simultaneous procedures, or patients who cannot view the video are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-institution randomized controlled trial enrolls adult women undergoing abdominally based autologous free-flap breast reconstruction after mastectomy and randomizes them to view a standardized postoperative opioid education video or receive usual care. The primary outcome is total post-discharge opioid use, measured from patient reports and prescription data. Patients with chronic preoperative opioid use, revision procedures, or multiple concurrent procedures are excluded. The intervention is designed to be easy to incorporate into routine postoperative workflows and to inform opioid prescribing guidelines for this population.
Why it matters
Potential benefit: If successful, the intervention could reduce unnecessary opioid use after reconstruction and help shape safer, data-driven prescribing guidelines.
How similar studies have gone: Brief educational interventions in other surgical populations have shown reductions in opioid prescribing and use, but this is the first randomized effort focused specifically on abdominal free-flap breast reconstruction.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States Recruiting
Study contacts
- Principal investigator: Jay Agarwal, MD — Huntsman Cancer Institute
- Study coordinator: Jay Agarwal, MD
- Email: jay.agarwal@hsc.utah.edu
- Phone: 801-585-2318
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.