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SAVE Trial: SAfe Opioid Use Video Education

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a video about safe opioid use changes how much opioid pain medicine patients take after leaving the hospital. The video covers careful use and safe disposal of leftover medicine. The study is for adult women having breast reconstruction using their own belly tissue after breast removal to treat or prevent cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Having breast reconstruction using their own belly tissue after a mastectomy (breast removal) to treat or prevent breast cancer.

Who can't join

  • Having another operation to redo breast reconstruction, such as using their own tissue after an implant reconstruction failed.
  • Having more than one procedure at the same time, such as breast removal and reconstruction.
  • Having a record of long-term opioid use before surgery or a long-term pain condition.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

UT