Clinical trial · Interventional
The Impact of Intraoperative Methadone on Postoperative Opioid Use
NCT07092475CI-TRIAL-00098008withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study team will no longer be enrolling patients for this research.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Opioid Use | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methadon | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intraoperative Methadone
- description
- 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.
- interventionNames
- Drug: Methadon
- type
- NO_INTERVENTION
- label
- Control
- description
- 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.
Primary outcomes (1)
- measure
- Total Postoperative Opioid Use
- timeFrame
- from the day of surgery until discharge, up to 4 weeks.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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, or chronic pain condition
References
Publications (41)
- BACKGROUNDCfDCa Prevention: Opioids. https://www.cdc.gov/opioids/index.html. Accessed October 26, 2021.
- BACKGROUNDHah 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. PMID 29049117
- BACKGROUNDOlds 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. PMID 30844024
- BACKGROUNDMercadante 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. PMID 37308798
- BACKGROUNDBarker 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. PMID 29979365
- BACKGROUNDMuetterties 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. PMID 38098953
- BACKGROUNDGort 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.