NCT07857655RecruitingPhase 4
Intraoperative Methadone for the Management of Postoperative Pain in Patients With Head and Neck Cancers
Intraoperative Methadone for Postoperative Pain Management in a Head and Neck Oncology Population - A Prospective, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
This phase IV trial compares how well methadone plus standard fentanyl given during surgery (intraoperative) works compared to intraoperative standard fentanyl alone in managing pain after surgery (postoperative) among patients with head and neck cancers. For most head and neck cancers, the standard treatment is surgery to remove the cancer followed by surgical reconstruction, which often requires tissue harvested from another part of the body-known as a "free flap tissue transfer". These procedures are highly complex, demand a two-surgeon team, and often take many hours to complete. The combination of multiple operative sites and extent of the surgery contributes to significant postoperative pain. Methadone is not yet used in the head and neck population but has been utilized in other subspecialties like spine and cardiac surgery. The benefits of methadone may include improved pain control in the first 72 hours postoperatively requiring less opioids postoperatively and improvement in overall pain scores. Giving intraoperative methadone plus standard fentanyl may work better than fentanyl alone in managing postoperative pain among patients with head and neck cancers.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 15 Sept 2026
- Start date
- 22 Sept 2026
- Primary completion date
- 29 Jul 2029
- Lead sponsor
- OHSU Knight Cancer Institute
- Diseases
- Head and neck cancer
- NCT number
- NCT07857655
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 58
- From 22 Sept 2026 to the primary completion date, 29 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pain patients treated with opioids for pathology unrelated to head and neck cancer and/or chronic pain patients, i.e. chronic back pain
- Positive screening at interview for illicit drug use, not including marijuana
- Drug screening is not routinely acquired prior to anesthesia per our institution's standard of care and policies. Any suspected abuse or use is guided by clinical evaluation. Patients with evidence of acute intoxication or concern for prior abuse history will be excluded per clinical judgement
- Currently on CYP therapies noted in the Food and Drug Administration (FDA) methadone pamphlet to have either decreased efficacy of therapy or reduced metabolism of methadone with concurrent use
- Rifampin, phenytoin, phenobarbital, carbamazepine, voriconazole, abacavir, amprenavir, darunavir+ritonavir, efavirenz, nelfinavir, nevirapine, ritonavir, telaprevir, lopinavir+ritonavir, saquinavir+ritonavir, tipranavir+ritonavir combination, didanosine, stavudine, zidovudine
Other illness
- Contraindications to methadone (American Society of Addiction Medicine \[ASAM\] criteria): hypersensitivity, severe respiratory depression, paralytic ileus - in which only hypersensitivity is relevant, since individuals undergoing surgery would not present with the latter
- Extensive surgical interventions that require additional assistance from outside services at the time of reconstruction (i.e. hypopharyngeal cancer also requiring esophagectomy)
- Head and neck cancers with intracranial components (direct, primary tumor extension, metastatic disease)
- Stage 3b chronic kidney disease or higher (estimated glomerular filtration rate \< 45)
Lab values
- Aspartate aminotransferase/alanine aminotransferase (AST/ALT) greater than two times the upper limit of normal
- Patients with a history of corrected QT interval (QTc) prolongation \> 500 ms
Other
- Patients will be excluded if they do not consent, are minors, are deemed part of a vulnerable population or lack decision-making capacity
- Current use of long-acting opioids
- Body mass index (BMI) \> 40
- Sleep apnea with an apnea-hypopnea index \> 30 without planned tracheostomy
Who the study is looking for
- Adults 18-89
- Patients with biopsy proven head and neck cancer\*. Diagnosis will be confirmed by Otolaryngology-Head and Neck Surgery (OTOHNS) team at our center
- Oral cavity, oropharyngeal, hypopharyngeal, laryngeal
- Undergoing surgical intervention with ablative and/or reconstructive OTOHNS surgeons for one of the following:
- Free flap reconstruction (single or double flaps including: radial forearm free flap \[RFFF\], osteocutaneous radial forearm flap \[OCRFF\], fibula free flap \[FFF\], anterolateral thigh \[ALT\], scapula flap, latissimus, gracilis, rectus sheath, pectoralis)
- Resections with pedicled flaps (e.g., pectoralis major, latissimus) with an expected case time of \> 4 hours
- Expected time of surgery is found in the surgery request and in our department, the surgeon puts in these orders
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OHSU Knight Cancer Institute Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.