Video education to promote safe opioid use after breast reconstruction
SAVE Trial: SAfe Opioid Use Video Education
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT07044583 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Salt Lake City, Utah
- University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Jay Agarwal, MD — Huntsman Cancer Institute/ University of Utah
- Study coordinator: Jay Agarwal, MD
- Email: jay.agarwal@hsc.utah.edu
- Phone: 801-585-2318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.