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NCT Number: NCT07044583

SAVE Trial: SAfe Opioid Use Video Education

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid Educational Video

Behavioral

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.

Primary outcomes

  1. Total Opioid Consumption

    Time frame: up to 2 weeks postoperative

    Total opioid consumption post-discharge from breast reconstruction, measured in Morphine Milligram Equivalents (MMEs).

  2. Days to Opioid Cessation

    Time frame: up to 2 weeks postoperative

    Total number of days until ceasing opioid use from breast reconstruction surgery to 2 weeks.

Secondary outcomes

  1. Opioids Prescribed Consumed

    Time frame: up to 2 weeks postoperative

    This outcome measure will report the percentage of opioids prescribed consumed from breast reconstruction surgery up to 2 weeks.

  2. Non-Opioid Analgesics Consumed

    Time frame: 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.

  3. Days to Non-Opioid Analgesics Cessation

    Time frame: up to 2 weeks postoperative

    Total number of days until ceasing of non-opioid analgesics from breast reconstruction surgery to 2 weeks.

  4. Patient-reported Daily Pain Scores

    Time frame: 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.

  5. Complication Types

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ethan Lester

CONTACT

[email protected]

203-450-2599

Jay Agarwal, MD

CONTACT

[email protected]

801-585-2318

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Acronym: SAVE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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