Breast CancerPhase 3NCT07092475
The Impact of Intraoperative Methadone on Postoperative Opioid Use
A Phase 3 study testing Methadon in people with Breast Cancer and Opioid Use, run by University of Utah at 1 site in United States.
Trial summary
This is a single-institution, randomized controlled trial to assess the effectiveness of intraoperative methadone on postoperative opioid use, pain control, and recovery in patients undergoing autologous breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Opioid Use
- What is being tested?
- Methadon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2025to Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 unilateral or bilateral autologous breast reconstruction with abdominally-based free flaps 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, or chronic pain condition
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-institution, randomized controlled trial to assess the effectiveness of intraoperative methadone on postoperative opioid use, pain control, and recovery in patients undergoing autologous breast reconstruction. Findings from this trial would inform subsequent perioperative pain protocols and allow the possible integration of intraoperative methadone into multimodal analgesia protocols.
Read the detailed description
Opioid over prescription remains a significant contributor to the opioid crisis in the United States. One major contributor to this epidemic is postoperative opioid prescribing-over 80% of surgical patients receive opioids for postoperative pain, placing many, especially opioid-naive patients, at risk for prolonged use, dependence, and addiction.
Many traditional pain management interventions rely on high doses of short-acting opioids such as hydromorphone and fentanyl. Though effective in the short term, these medications often have fluctuating blood concentration levels, which can lead to ineffective pain control, increased side effects, and higher risk for long-term dependence and chronic use. Despite national efforts to promote better recovery pathways through multimodal pain management plans, significant variation in postoperative opioid prescribing and consumption patterns remains, and over 40% of surgical patients still do not achieve adequate relief of pain.
An alternative solution is intraoperative methadone, a long-acting synthetic opioid with a pharmacologic profile that potentially offers more stable and longer-lasting pain relief. Unlike short-acting opioids, a single dose of methadone given intraoperatively has been shown to be capable of maintaining analgesic levels for up to 24-36 hours, potentially reducing total postoperative opioid requirements.
The use of intraoperative methadone for cardiac, spine, and ambulatory procedures is well-established, demonstrating that methadone leads to significant reductions in perioperative opioid use and pain scores postoperatively without increased risk of opioid side effects. In addition, preliminary data from a 2022 study on DIEP flap patients and a 2024 retrospective cohort study on mastectomy patients both suggest that intraoperative methadone significantly reduces postoperative opioid requirements.
Preliminary retrospective data from revealed that patients receiving intraoperative methadone for autologous breast reconstruction had significantly lower postoperative opioid consumption compared to those who did not receive intraoperative methadone, with a 37.2% reduction in total inpatient opioid use. However, prospective, randomized data in this population is currently lacking.
This is a single-institution, randomized controlled trial to assess the effectiveness of intraoperative methadone on postoperative opioid use, pain control, and recovery in patients undergoing autologous breast reconstruction. Findings from this trial would inform subsequent perioperative pain protocols and allow the possible integration of intraoperative methadone into multimodal analgesia protocols.
Patients will be randomized to either a methadone cohort or a control cohort. Aside from this intervention, both groups will undergo the same standardized intraoperative anesthetic protocol. Surgical care will not be altered for study purposes.
Postoperative care will follow institutional protocols and will not be altered for study purposes. Patients in both cohorts will receive the same standardized postoperative analgesic regimen, including as-needed (PRN) administration of short-acting opioids (e.g., IV hydromorphone, IV fentanyl), acetaminophen, and antiemetics. NSAIDs such as ketorolac or celecoxib will be avoided.
Patients will be monitored daily for opioid-related side effects including nausea, vomiting, constipation, sedation, and respiratory depression. Nausea will be assessed both through direct patient report and review of antiemetic administration (e.g., ondansetron, metoclopramide).
- Conditions
- Breast Cancer, Opioid Use
- Being tested
- Methadon
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadonDrug
Also called Diskets, Methadone Intensol, Methadose
A long-acting synthetic opioid with a pharmacologic profile that potentially offers more stable and longer-lasting pain relief.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Methadone | Experimental | the methadone group will receive a single dose of intravenous methadone administered within 30 minutes after induction of anesthesia by the attending anesthesiologist. The standard dose will be 20 mg, except for patients under 60 kg or over 65 years of age, who will receive 15 mg. Receives: Drug: Methadon |
| Control | No intervention | The control group will not receive methadone and will instead receive a standard dose of 1 mg IV hydromorphone within the final 30-45 minutes of the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Opioid Use
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction.
Total perioperative opioid consumption will be measured in morphine milligram equivalents (MMEs), a standardized measure to quantify the strength of opioid doses compared to morphine.
This outcome measure will be assessed from the day of surgery until discharge, up to 4 weeks.
Measured: from the day of surgery until discharge, up to 4 weeks.
Secondary outcomes (9)
Patient-Reported Pain Scores - Visual Analog Scale
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction.
This outcome measure will assess visual analog scale scores, a measurement to assess pain by having subjects mark pain on a line. Visual analog scale scores range from 0-10, with lower scores indicating less perceived pain and higher scores indicating more perceived pain.
Measured: from the day of surgery until discharge, up to 4 weeks.
Patient-Reported Pain Scores - Pain Interference Score
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction.
This outcome measure will assess pain interference scores, a measure for assessing how pain impacts daily life.
Pain Interference scores range from 0-10, with lower scores indicating less interference with daily life and higher scores indicating more interference with daily life.
Measured: from the day of surgery until discharge, up to 4 weeks.
Patient-Reported Pain Scores - Patient Pain Management Satisfaction Scale
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction.
This outcome measure will assess patient pain management satisfaction scale scores in the immediate postoperative period.
The Patient Pain Management Satisfaction Scale is a single-item, self-reported question, "Please write your satisfaction with your pain management". Patient Pain Management Satisfaction Scale scores range from 0 to 100, with lower scores indicating worse satisfaction with pain management and higher scores indicating better satisfaction with pain management.
Measured: from the day of surgery until discharge, up to 4 weeks.
Length of hospital stay
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction.
Length of hospital stay will be captured in 24-hour intervals. This outcome measure will report the mean hospital stay in days.
Measured: from the day of surgery until discharge, up to 4 weeks.
Proportion of participants utilizing non-opioid analgesics
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction.
This outcome measure will report the proportion of participants who used non-opioid analgesics such as Tylenol (Acetaminophen) and NSAIDs.
Measured: from the day of surgery until discharge, up to 4 weeks.
Days of non-opioid analgesics use
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction.
This outcome measure will report the mean days research participants took non-opioid analgesics.
Measured: from the day of surgery until discharge, up to 4 weeks.
Opioid-related side effects
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction.
Patients will be monitored daily for opioid-related side effects, including nausea, vomiting, constipation, sedation, and respiratory depression. This outcome measure will report the proportion of subjects who experience each opioid-related side effect.
Measured: from the day of surgery until discharge, up to 4 weeks.
Time to opioid cessation
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction.
This outcome measure will report the mean time in days to opioid cessation for each group.
Measured: from the day of surgery until discharge, up to 4 weeks.
Complication Rates
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction.
Patients will be monitored daily for surgery complications, including wound issues, seroma/hematoma, infection, takeback to OR, readmission, ED visits, and reoperation. This outcome measure will report the proportion of subjects who experience each complications.
Measured: from the day of surgery until discharge, up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Why it stopped: The study team will no longer be enrolling patients for this research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alvin Kwok, MD, MPH, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092475
- Sponsor's protocol ID
- HCI182069
- Status last verified
- Nov 2025
- First submitted
- 21 Jul 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
CfDCa Prevention: Opioids. https://www.cdc.gov/opioids/index.html. Accessed October 26, 2021.
Hah 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 29049117Olds C, Spataro E, Li K, Kandathil C, Most SP. Assessment of Persistent and Prolonged Postoperative Opioid Use Among Patients Undergoing Plastic and Reconstructive Surgery. JAMA Facial Plast Surg. 2019 Jul 1;21(4):286-291. doi: 10.1001/jamafacial.2018.2035.
PubMed 30844024Mercadante S. Intravenous Methadone for Perioperative and Chronic Cancer Pain: A Review of the Literature. Drugs. 2023 Jul;83(10):865-871. doi: 10.1007/s40265-023-01876-7. Epub 2023 Jun 13.
PubMed 37308798Barker JC, DiBartola K, Wee C, Andonian N, Abdel-Rasoul M, Lowery D, Janis JE. Preoperative Multimodal Analgesia Decreases Postanesthesia Care Unit Narcotic Use and Pain Scores in Outpatient Breast Surgery. Plast Reconstr Surg. 2018 Oct;142(4):443e-450e. doi: 10.1097/PRS.0000000000004804.
PubMed 29979365Muetterties 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 38098953Gort N, van Gaal BGI, Tielemans HJP, Ulrich DJO, Hummelink S. Positive effects of the enhanced recovery after surgery (ERAS) protocol in DIEP flap breast reconstruction. Breast. 2021 Dec;60:53-57. doi: 10.1016/j.breast.2021.08.010. Epub 2021 Aug 20.
PubMed 34464847Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Shear T, Parikh KN, Patel SS, Gupta DK. Intraoperative Methadone for the Prevention of Postoperative Pain: A Randomized, Double-blinded Clinical Trial in Cardiac Surgical Patients. Anesthesiology. 2015 May;122(5):1112-22. doi: 10.1097/ALN.0000000000000633.
PubMed 25837528Kharasch ED, Brunt LM, Blood J, Komen H. Intraoperative Methadone in Next-day Discharge Outpatient Surgery: A Randomized, Double-blinded, Dose-finding Pilot Study. Anesthesiology. 2023 Oct 1;139(4):405-419. doi: 10.1097/ALN.0000000000004663.
PubMed 37350677Udelsmann A, Maciel FG, Servian DC, Reis E, de Azevedo TM, Melo Mde S. Methadone and morphine during anesthesia induction for cardiac surgery. Repercussion in postoperative analgesia and prevalence of nausea and vomiting. Rev Bras Anestesiol. 2011 Nov-Dec;61(6):695-701. doi: 10.1016/S0034-7094(11)70078-2. English, Multiple languages.
PubMed 22063370Carle N, Nikolajsen L, Uhrbrand CG. Respiratory Depression Following Intraoperative Methadone: A Retrospective Cohort Study. Anesth Analg. 2025 Mar 1;140(3):516-523. doi: 10.1213/ANE.0000000000007018. Epub 2025 Feb 14.
PubMed 38814334Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Vender JS, Benson J, Newmark RL. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial. Anesthesiology. 2017 May;126(5):822-833. doi: 10.1097/ALN.0000000000001609.
PubMed 28418966Bernstein JL, Lu Wang M, Huang H, Otterburn DM. Intra-operative Methadone Decreases Post-operative Pain and Opioid Use in DIEP Flap Breast Patients: A New ERAS Protocol. Plast Reconstr Surg Glob Open. 2022;10(10 Suppl):92. Published 2022 Oct 24. doi:10.1097/01.GOX.0000898792.35273.f6
NIDA. Drug Overdose Deaths: Facts and Figures. National Institute on Drug Abuse website. https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates. August 21, 2024 Accessed November 12, 2024.
Centers for Disease Control and Prevention. State Unintentional Drug Overdose Reporting System (SUDORS). Preliminary Data. Atlanta, GA: US Department of Health and Human Services, CDC; November 12, 2024. Access at: https://www.cdc.gov/overdose-prevention/data-research/facts-stats/sudors-dashboard-fatal-overdose-data.html
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
- The Impact of Intraoperative Methadone on Postoperative Opioid Use
- ClinicalTrials.gov ID
- NCT07092475
- Acronym / sponsor ID
- HCI182069
- Conditions
- Breast Cancer, Opioid Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study team will no longer be enrolling patients for this research.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 30 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.
This is a single-institution, randomized controlled trial to assess the effectiveness of intraoperative methadone on postoperative opioid use, pain control, and recovery in patients undergoing autologous breast reconstruction. Findings from this trial would inform subsequent perioperative pain protocols and allow the possible integration of intraoperative methadone into multimodal analgesia protocols.
Detailed description
Opioid over prescription remains a significant contributor to the opioid crisis in the United States. One major contributor to this epidemic is postoperative opioid prescribing-over 80% of surgical patients receive opioids for postoperative pain, placing many, especially opioid-naive patients, at risk for prolonged use, dependence, and addiction.
Many traditional pain management interventions rely on high doses of short-acting opioids such as hydromorphone and fentanyl. Though effective in the short term, these medications often have fluctuating blood concentration levels, which can lead to ineffective pain control, increased side effects, and higher risk for long-term dependence and chronic use. Despite national efforts to promote better recovery pathways through multimodal pain management plans, significant variation in postoperative opioid prescribing and consumption patterns remains, and over 40% of surgical patients still do not achieve adequate relief of pain.
An alternative solution is intraoperative methadone, a long-acting synthetic opioid with a pharmacologic profile that potentially offers more stable and longer-lasting pain relief. Unlike short-acting opioids, a single dose of methadone given intraoperatively has been shown to be capable of maintaining analgesic levels for up to 24-36 hours, potentially reducing total postoperative opioid requirements.
The use of intraoperative methadone for cardiac, spine, and ambulatory procedures is well-established, demonstrating that methadone leads to significant reductions in perioperative opioid use and pain scores postoperatively without increased risk of opioid side effects. In addition, preliminary data from a 2022 study on DIEP flap patients and a 2024 retrospective cohort study on mastectomy patients both suggest that intraoperative methadone significantly reduces postoperative opioid requirements.
Preliminary retrospective data from revealed that patients receiving intraoperative methadone for autologous breast reconstruction had significantly lower postoperative opioid consumption compared to those who did not receive intraoperative methadone, with a 37.2% reduction in total inpatient opioid use. However, prospective, randomized data in this population is currently lacking.
This is a single-institution, randomized controlled trial to assess the effectiveness of intraoperative methadone on postoperative opioid use, pain control, and recovery in patients undergoing autologous breast reconstruction. Findings from this trial would inform subsequent perioperative pain protocols and allow the possible integration of intraoperative methadone into multimodal analgesia protocols.
Patients will be randomized to either a methadone cohort or a control cohort. Aside from this intervention, both groups will undergo the same standardized intraoperative anesthetic protocol. Surgical care will not be altered for study purposes.
Postoperative care will follow institutional protocols and will not be altered for study purposes. Patients in both cohorts will receive the same standardized postoperative analgesic regimen, including as-needed (PRN) administration of short-acting opioids (e.g., IV hydromorphone, IV fentanyl), acetaminophen, and antiemetics. NSAIDs such as ketorolac or celecoxib will be avoided.
Patients will be monitored daily for opioid-related side effects including nausea, vomiting, constipation, sedation, and respiratory depression. Nausea will be assessed both through direct patient report and review of antiemetic administration (e.g., ondansetron, metoclopramide).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Methadone | Experimental | Drug: Methadonthe methadone group will receive a single dose of intravenous methadone administered within 30 minutes after induction of anesthesia by the attending anesthesiologist. The standard dose will be 20 mg, except for patients under 60 kg or over 65 years of age, who will receive 15 mg. |
| Control | No intervention | –The control group will not receive methadone and will instead receive a standard dose of 1 mg IV hydromorphone within the final 30-45 minutes of the procedure. |
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 unilateral or bilateral autologous breast reconstruction with abdominally-based free flaps 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, or 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 |
|---|---|---|
| MethadonAlso: Diskets, Methadone Intensol, MethadoseA long-acting synthetic opioid with a pharmacologic profile that potentially offers more stable and longer-lasting pain relief. | Drug | Intraoperative Methadone |
Primary outcome
Total Postoperative Opioid Use
Time frame: from the day of surgery until discharge, up to 4 weeks.
To evaluate the impact of intraoperative methadone administration on postoperative opioid use and pain control in patients undergoing autologous breast reconstruction. Total perioperative opioid consumption will be measured in morphine milligram equivalents (MMEs), a standardized measure to quantify the strength of opioid doses compared to morphine. This outcome measure will be assessed from the day of surgery until discharge, up to 4 weeks.
9 secondary outcomes
Patient-Reported Pain Scores - Visual Analog Scale
Time frame: from the day of surgery until discharge, up to 4 weeks.
Patient-Reported Pain Scores - Pain Interference Score
Time frame: from the day of surgery until discharge, up to 4 weeks.
Patient-Reported Pain Scores - Patient Pain Management Satisfaction Scale
Time frame: from the day of surgery until discharge, up to 4 weeks.
Length of hospital stay
Time frame: from the day of surgery until discharge, up to 4 weeks.
Proportion of participants utilizing non-opioid analgesics
Time frame: from the day of surgery until discharge, up to 4 weeks.
Days of non-opioid analgesics use
Time frame: from the day of surgery until discharge, up to 4 weeks.
Opioid-related side effects
Time frame: from the day of surgery until discharge, up to 4 weeks.
Time to opioid cessation
Time frame: from the day of surgery until discharge, up to 4 weeks.
Complication Rates
Time frame: from the day of surgery until discharge, up to 4 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- BackgroundCfDCa Prevention: Opioids. https://www.cdc.gov/opioids/index.html. Accessed October 26, 2021.
- Background: PubMed 29049117Hah 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.
- Background: PubMed 30844024Olds C, Spataro E, Li K, Kandathil C, Most SP. Assessment of Persistent and Prolonged Postoperative Opioid Use Among Patients Undergoing Plastic and Reconstructive Surgery. JAMA Facial Plast Surg. 2019 Jul 1;21(4):286-291. doi: 10.1001/jamafacial.2018.2035.
- Background: PubMed 37308798Mercadante S. Intravenous Methadone for Perioperative and Chronic Cancer Pain: A Review of the Literature. Drugs. 2023 Jul;83(10):865-871. doi: 10.1007/s40265-023-01876-7. Epub 2023 Jun 13.
- Background: PubMed 29979365Barker JC, DiBartola K, Wee C, Andonian N, Abdel-Rasoul M, Lowery D, Janis JE. Preoperative Multimodal Analgesia Decreases Postanesthesia Care Unit Narcotic Use and Pain Scores in Outpatient Breast Surgery. Plast Reconstr Surg. 2018 Oct;142(4):443e-450e. doi: 10.1097/PRS.0000000000004804.
- 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 34464847Gort N, van Gaal BGI, Tielemans HJP, Ulrich DJO, Hummelink S. Positive effects of the enhanced recovery after surgery (ERAS) protocol in DIEP flap breast reconstruction. Breast. 2021 Dec;60:53-57. doi: 10.1016/j.breast.2021.08.010. Epub 2021 Aug 20.
- Background: PubMed 25837528Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Shear T, Parikh KN, Patel SS, Gupta DK. Intraoperative Methadone for the Prevention of Postoperative Pain: A Randomized, Double-blinded Clinical Trial in Cardiac Surgical Patients. Anesthesiology. 2015 May;122(5):1112-22. doi: 10.1097/ALN.0000000000000633.
- Background: PubMed 37350677Kharasch ED, Brunt LM, Blood J, Komen H. Intraoperative Methadone in Next-day Discharge Outpatient Surgery: A Randomized, Double-blinded, Dose-finding Pilot Study. Anesthesiology. 2023 Oct 1;139(4):405-419. doi: 10.1097/ALN.0000000000004663.
- Background: PubMed 22063370Udelsmann A, Maciel FG, Servian DC, Reis E, de Azevedo TM, Melo Mde S. Methadone and morphine during anesthesia induction for cardiac surgery. Repercussion in postoperative analgesia and prevalence of nausea and vomiting. Rev Bras Anestesiol. 2011 Nov-Dec;61(6):695-701. doi: 10.1016/S0034-7094(11)70078-2. English, Multiple languages.
- Background: PubMed 38814334Carle N, Nikolajsen L, Uhrbrand CG. Respiratory Depression Following Intraoperative Methadone: A Retrospective Cohort Study. Anesth Analg. 2025 Mar 1;140(3):516-523. doi: 10.1213/ANE.0000000000007018. Epub 2025 Feb 14.
- Background: PubMed 28418966Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Vender JS, Benson J, Newmark RL. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial. Anesthesiology. 2017 May;126(5):822-833. doi: 10.1097/ALN.0000000000001609.
- 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. This study is not recruiting at the moment.
Alvin Kwok, MD, MPH 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 Phase 3 study testing Methadon in people with Breast Cancer and Opioid Use, 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: withdrawn, 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Postoperative Opioid Use (time frame: from the day of surgery until discharge, up to 4 weeks.). 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 NCT07092475, which also lists 41 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.