SAVE Trial: SAfe Opioid Use Video Education

Not Applicable

Not yet recruiting

• Conditions: Breast Reconstruction; Breast Cancer

• Registration Number: NCT07044583
• Lead Sponsor: University of Utah

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.

Detailed Description

Opioids are widely overprescribed and overused after surgery, contributing to the current opioid misuse crisis which affects more than 10 million Americans annually. In the breast reconstruction after mastectomy population, studies report as many as 47% of patients go on to become prolonged users of opioids.

The primary goal is to 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. The proposed study 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 project is directly relevant to the mission of the AHRQ to "improve health care patient safety and to provide a 360-degree view of the patient." Specifically, 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.

Patients will be randomized to an opioid video vs. no opioid video cohort by a block randomization scheme based on a predefined computer-generated sequence (six blocks, six numbers per block) in a 1:1 intervention: no intervention ratio. Patients in the opioid video cohort will watch a 3-minute education video on proper opioid use preoperatively. The video includes information on (1) how to consume appropriate over-the-counter pain medication alongside opioids for optimal pain control, (2) how prescribed opioids should be used only to treat pain related to the surgery, and (3) the proper disposal of unused opioids. The video was created through the University of Utah Office of Patient Experience. Feedback regarding the educational content was provided by surgeons, pain management physicians, and pharmacists throughout the process.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-03
• Study Start: 2025-08-01
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Days to Opioid Cessation	up to 2 weeks postoperative	Total number of days until ceasing opioid use from breast reconstruction surgery to 2 weeks.
Total Opioid Consumption	up to 2 weeks postoperative	Total opioid consumption post-discharge from breast reconstruction, measured in Morphine Milligram Equivalents (MMEs).

Secondary Outcome Measures

Name	Time	Method
Opioids Prescribed Consumed	up to 2 weeks postoperative	This outcome measure will report the percentage of opioids prescribed consumed from breast reconstruction surgery up to 2 weeks.
Patient-reported Daily Pain Scores	up to 2 weeks postoperative	Patient-reported daily pain scores from breast reconstruction surgery to 2 weeks.; Pain Scores are numerical ratings of self-reported pain intensity from 0-10. Lower scores indicate less pain, and higher score indicate more pain.; This outcome measure will report the mean Patient-reported Daily Pain Scores.
Days to Non-Opioid Analgesics Cessation	up to 2 weeks postoperative	Total number of days until ceasing of non-opioid analgesics from breast reconstruction surgery to 2 weeks.
Complication Types	up to 2 weeks postoperative	This outcome measure will report the frequency of the following breast reconstruction complications: * Poor wound healing: skin necrosis, dehiscence of wound; * Seroma/ Hematoma; * Infection; * Takeback to the operating room pre-discharge; * Unplanned readmission; * Emergency Department visit for any reason; * Reoperation
Non-Opioid Analgesics Consumed	up to 2 weeks postoperative	This outcome measure will report the amount and type of non-opioid analgesics consumed from breast reconstruction surgery to 2 weeks.

Trial Locations

Locations (1)

University of Utah Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States