Breast ReconstructionSAVENCT07044583
SAVE Trial: SAfe Opioid Use Video Education
A study testing Opioid Educational Video in people with Breast Reconstruction and Breast Cancer, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction, Breast Cancer
- What is being tested?
- Opioid Educational Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Reconstruction, Breast Cancer
- Being tested
- Opioid Educational Video
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Educational VideoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption
Total opioid consumption post-discharge from breast reconstruction, measured in Morphine Milligram Equivalents (MMEs).
Measured: up to 2 weeks postoperative
Days to Opioid Cessation
Total number of days until ceasing opioid use from breast reconstruction surgery to 2 weeks.
Measured: up to 2 weeks postoperative
Secondary outcomes (5)
Opioids Prescribed Consumed
This outcome measure will report the percentage of opioids prescribed consumed from breast reconstruction surgery up to 2 weeks.
Measured: up to 2 weeks postoperative
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.
Measured: up to 2 weeks postoperative
Days to Non-Opioid Analgesics Cessation
Total number of days until ceasing of non-opioid analgesics from breast reconstruction surgery to 2 weeks.
Measured: up to 2 weeks postoperative
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.
Measured: up to 2 weeks postoperative
Complication Types
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
Measured: up to 2 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start27 Oct 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay Agarwal, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044583
- Sponsor's protocol ID
- HCI186179
- Acronym
- SAVE
- Status last verified
- Nov 2025
- First submitted
- 23 Jun 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Statistics NCfDA. Opioid Epidemic: Addiction Statistics. Accessed February 16, 2024, https://drugabusestatistics.org/opioid-epidemic/
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.
PubMed 29176408Samuel AR, Fuhr L, DeGeorge BR Jr, Black J, Campbell C, Stranix JT. Prolonged Opioid Use Among Opioid-Naive Women Undergoing Breast Reconstructive Surgery. Arch Plast Surg. 2022 May 27;49(3):339-345. doi: 10.1055/s-0042-1744419. eCollection 2022 May.
PubMed 35832151(OPEN) OPEN. OPEN Prescribing Recommendations. This document was retrieved from a website with the URL: https://doi.org/10.56137/OPEN.000054
Batdorf NJ, Lemaine V, Lovely JK, Ballman KV, Goede WJ, Martinez-Jorge J, Booth-Kowalczyk AL, Grubbs PL, Bungum LD, Saint-Cyr M. Enhanced recovery after surgery in microvascular breast reconstruction. J Plast Reconstr Aesthet Surg. 2015 Mar;68(3):395-402. doi: 10.1016/j.bjps.2014.11.014. Epub 2014 Nov 21.
PubMed 25488326Muetterties CE, Taylor JM, Kaeding DE, Morales RR, Nguyen AV, Kwan L, Tseng CY, Delong MR, Festekjian JH. Enhanced Recovery after Surgery Protocol Decreases Length of Stay and Postoperative Narcotic Use in Microvascular Breast Reconstruction. Plast Reconstr Surg Glob Open. 2023 Dec 14;11(12):e5444. doi: 10.1097/GOX.0000000000005444. eCollection 2023 Dec.
PubMed 38098953Pierzchajlo N, Zibitt M, Hinson C, Stokes JA, Neil ZD, Pierzchajlo G, Gendreau J, Buchanan PJ. Enhanced recovery after surgery pathways for deep inferior epigastric perforator flap breast reconstruction: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2023 Dec;87:259-272. doi: 10.1016/j.bjps.2023.10.058. Epub 2023 Oct 15.
PubMed 37924717Temple-Oberle C, Shea-Budgell MA, Tan M, Semple JL, Schrag C, Barreto M, Blondeel P, Hamming J, Dayan J, Ljungqvist O; ERAS Society. Consensus Review of Optimal Perioperative Care in Breast Reconstruction: Enhanced Recovery after Surgery (ERAS) Society Recommendations. Plast Reconstr Surg. 2017 May;139(5):1056e-1071e. doi: 10.1097/PRS.0000000000003242.
PubMed 28445352Tedesco D, Mayo JL. Decreasing Opioid Prescriptions in Women Undergoing Mastectomy and Breast Reconstruction. Pain Manag Nurs. 2020 Aug;21(4):339-344. doi: 10.1016/j.pmn.2020.02.068. Epub 2020 Apr 10.
PubMed 32280011Melnyk M, Casey RG, Black P, Koupparis AJ. Enhanced recovery after surgery (ERAS) protocols: Time to change practice? Can Urol Assoc J. 2011 Oct;5(5):342-8. doi: 10.5489/cuaj.11002.
PubMed 22031616Kadakia NN, Rogers RL, Reed JB, Dark ER, Plake KI. Patient education interventions for prescription opioids: A systematic review. J Am Pharm Assoc (2003). 2020 Jul-Aug;60(4):e31-e42. doi: 10.1016/j.japh.2020.02.013. Epub 2020 Apr 3.
PubMed 32253087Rose KR, Christie BM, Block LM, Rao VK, Michelotti BF. Opioid Prescribing and Consumption Patterns following Outpatient Plastic Surgery Procedures. Plast Reconstr Surg. 2019 Mar;143(3):929-938. doi: 10.1097/PRS.0000000000005351.
PubMed 30817667Zhang KK, Blum KM, Chu JJ, Sharma S, Skoracki RJ, Moore AM, Janis JE, Barker JC. Reducing Opioid Overprescribing through Procedure-specific Prescribing Guidelines. Plast Reconstr Surg Glob Open. 2023 Jan 20;11(1):e4776. doi: 10.1097/GOX.0000000000004776. eCollection 2023 Jan.
PubMed 36699205Goldberg RF. The Opioid Crisis: The Surgeon's Role. Adv Surg. 2019 Sep;53:305-325. doi: 10.1016/j.yasu.2019.04.015. Epub 2019 May 17. No abstract available.
PubMed 31327454Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458.
PubMed 29049117
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAVE Trial: SAfe Opioid Use Video Education
- ClinicalTrials.gov ID
- NCT07044583
- Acronym / sponsor ID
- SAVE / HCI186179
- Conditions
- Breast Reconstruction, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Opioid Video | Experimental | Behavioral: Opioid Educational VideoPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Educational VideoThe 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. | Behavioural | Opioid Video |
Primary outcome
Total Opioid Consumption
Time frame: up to 2 weeks postoperative
Total opioid consumption post-discharge from breast reconstruction, measured in Morphine Milligram Equivalents (MMEs).
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.
5 secondary outcomes
Opioids Prescribed Consumed
Time frame: up to 2 weeks postoperative
Non-Opioid Analgesics Consumed
Time frame: up to 2 weeks postoperative
Days to Non-Opioid Analgesics Cessation
Time frame: up to 2 weeks postoperative
Patient-reported Daily Pain Scores
Time frame: up to 2 weeks postoperative
Complication Types
Time frame: up to 2 weeks postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- BackgroundStatistics NCfDA. Opioid Epidemic: Addiction Statistics. Accessed February 16, 2024, https://drugabusestatistics.org/opioid-epidemic/
- Background: PubMed 29176408Marcusa 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.
- Background: PubMed 35832151Samuel AR, Fuhr L, DeGeorge BR Jr, Black J, Campbell C, Stranix JT. Prolonged Opioid Use Among Opioid-Naive Women Undergoing Breast Reconstructive Surgery. Arch Plast Surg. 2022 May 27;49(3):339-345. doi: 10.1055/s-0042-1744419. eCollection 2022 May.
- Background(OPEN) OPEN. OPEN Prescribing Recommendations. This document was retrieved from a website with the URL: https://doi.org/10.56137/OPEN.000054
- Background: PubMed 25488326Batdorf NJ, Lemaine V, Lovely JK, Ballman KV, Goede WJ, Martinez-Jorge J, Booth-Kowalczyk AL, Grubbs PL, Bungum LD, Saint-Cyr M. Enhanced recovery after surgery in microvascular breast reconstruction. J Plast Reconstr Aesthet Surg. 2015 Mar;68(3):395-402. doi: 10.1016/j.bjps.2014.11.014. Epub 2014 Nov 21.
- Background: PubMed 38098953Muetterties CE, Taylor JM, Kaeding DE, Morales RR, Nguyen AV, Kwan L, Tseng CY, Delong MR, Festekjian JH. Enhanced Recovery after Surgery Protocol Decreases Length of Stay and Postoperative Narcotic Use in Microvascular Breast Reconstruction. Plast Reconstr Surg Glob Open. 2023 Dec 14;11(12):e5444. doi: 10.1097/GOX.0000000000005444. eCollection 2023 Dec.
- Background: PubMed 37924717Pierzchajlo N, Zibitt M, Hinson C, Stokes JA, Neil ZD, Pierzchajlo G, Gendreau J, Buchanan PJ. Enhanced recovery after surgery pathways for deep inferior epigastric perforator flap breast reconstruction: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2023 Dec;87:259-272. doi: 10.1016/j.bjps.2023.10.058. Epub 2023 Oct 15.
- Background: PubMed 28445352Temple-Oberle C, Shea-Budgell MA, Tan M, Semple JL, Schrag C, Barreto M, Blondeel P, Hamming J, Dayan J, Ljungqvist O; ERAS Society. Consensus Review of Optimal Perioperative Care in Breast Reconstruction: Enhanced Recovery after Surgery (ERAS) Society Recommendations. Plast Reconstr Surg. 2017 May;139(5):1056e-1071e. doi: 10.1097/PRS.0000000000003242.
- Background: PubMed 32280011Tedesco D, Mayo JL. Decreasing Opioid Prescriptions in Women Undergoing Mastectomy and Breast Reconstruction. Pain Manag Nurs. 2020 Aug;21(4):339-344. doi: 10.1016/j.pmn.2020.02.068. Epub 2020 Apr 10.
- Background: PubMed 22031616Melnyk M, Casey RG, Black P, Koupparis AJ. Enhanced recovery after surgery (ERAS) protocols: Time to change practice? Can Urol Assoc J. 2011 Oct;5(5):342-8. doi: 10.5489/cuaj.11002.
- Background: PubMed 32253087Kadakia NN, Rogers RL, Reed JB, Dark ER, Plake KI. Patient education interventions for prescription opioids: A systematic review. J Am Pharm Assoc (2003). 2020 Jul-Aug;60(4):e31-e42. doi: 10.1016/j.japh.2020.02.013. Epub 2020 Apr 3.
- Background: PubMed 30817667Rose KR, Christie BM, Block LM, Rao VK, Michelotti BF. Opioid Prescribing and Consumption Patterns following Outpatient Plastic Surgery Procedures. Plast Reconstr Surg. 2019 Mar;143(3):929-938. doi: 10.1097/PRS.0000000000005351.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jay Agarwal, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Educational Video in people with Breast Reconstruction and Breast Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Agarwal, MD (801-585-2318, jay.agarwal@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Consumption (time frame: up to 2 weeks postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07044583, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.