SAVE Trial: SAfe Opioid Use Video Education
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Opioid Educational Video
BehavioralThe 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Opioid VideoExperimental treatment 1 intervention
Group B: Regular CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Total Opioid Consumption
Total opioid consumption post-discharge from breast reconstruction, measured in Morphine Milligram Equivalents (MMEs).
Time frame
up to 2 weeks postoperative2
Days to Opioid Cessation
Total number of days until ceasing opioid use from breast reconstruction surgery to 2 weeks.
Time frame
up to 2 weeks postoperativeSecondary outcomes
1
Opioids Prescribed Consumed
This outcome measure will report the percentage of opioids prescribed consumed from breast reconstruction surgery up to 2 weeks.
Time frame
up to 2 weeks postoperative2
Non-Opioid Analgesics Consumed
This outcome measure will report the amount and type of non-opioid analgesics consumed from breast reconstruction surgery to 2 weeks.
Time frame
up to 2 weeks postoperative3
Days to Non-Opioid Analgesics Cessation
Total number of days until ceasing of non-opioid analgesics from breast reconstruction surgery to 2 weeks.
Time frame
up to 2 weeks postoperative4
Patient-reported Daily Pain Scores
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.
Time frame
up to 2 weeks postoperativeSponsors and contacts
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Source ClinicalTrials.gov