SAVE Trial: SAfe Opioid Use Video Education

NCT07044583 | Recruiting

• 1 other identifier: HCI186179
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Total Opioid Consumption

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

  up to 2 weeks postoperative

• Days to Opioid Cessation

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

  up to 2 weeks postoperative

Secondary Outcomes (5)

• Opioids Prescribed Consumed

  up to 2 weeks postoperative

• Non-Opioid Analgesics Consumed

  up to 2 weeks postoperative

• Days to Non-Opioid Analgesics Cessation

  up to 2 weeks postoperative

• Patient-reported Daily Pain Scores

  up to 2 weeks postoperative

• Complication Types

  up to 2 weeks postoperative

Study Arms (2)

Opioid Video

EXPERIMENTAL

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.

Behavioral: Opioid Educational Video

Regular Care

NO INTERVENTION

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 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.

Opioid Video

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (39)

• Statistics NCfDA. Opioid Epidemic: Addiction Statistics. Accessed February 16, 2024, https://drugabusestatistics.org/opioid-epidemic/

  BACKGROUND

• Marcusa DP, Mann RA, Cron DC, Fillinger BR, Rzepecki AK, Kozlow JH, Momoh A, Englesbe M, Brummett C, Waljee JF. Prescription Opioid Use among Opioid-Naive Women Undergoing Immediate Breast Reconstruction. Plast Reconstr Surg. 2017 Dec;140(6):1081-1090. doi: 10.1097/PRS.0000000000003832.

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jay Agarwal, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jay Agarwal, MD

CONTACT

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

Ethan Lester

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to a 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.

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)