Recruiting

Opioid Education

Sponsor:

University of Utah

Code:

NCT07044583

Conditions

Breast Reconstruction

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Opioid Educational Video

Study Details

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.

Conditions

Breast Reconstruction

Breast Cancer

Study ID

NCT07044583

Start date

Oct 27, 2025

Status verified date

Nov, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Opioid Video

Patients in the opioid video cohort will watch a 3-minute education video on proper opioid use preoperatively. All patients who consent to study participation will be given the same surgical care and inpatient intraoperative and postoperative analgesic regimen regardless of cohort allocation.

no intervention: Regular Care

All patients who consent to study participation will be given the same surgical care and inpatient intraoperative and postoperative analgesic regimen regardless of cohort allocation.

Interventions

Opioid Educational Video

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 outcome measure

  • Total Opioid Consumption [ Time Frame: up to 2 weeks postoperative ]
  • Days to Opioid Cessation [ Time Frame: up to 2 weeks postoperative ]

Central Contacts and Locations

Central contacts

Jay Agarwal, MD

801-585-2318jay.agarwal@hsc.utah.edu

Ethan Lester

203-450-2599ethan.lester@utah.edu

Locations

University of Utah Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

More Information

Sponsor

University of Utah

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-11-26.