NCT07857655 · OHSU Knight Cancer Institute
Intraoperative Methadone for the Management of Postoperative Pain in Patients With Head and Neck Cancers
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Electronic Health Record Review
Ancillary studies
DRUG
Fentanyl
Given SOC fentanyl
DEVICE
Laryngoscopy
Undergo SOC laryngoscopy
DRUG
Methadone
Given IV
PROCEDURE
Surgical Procedure
Undergo SOC surgery
OTHER
Survey Administration
Ancillary studies
Primary outcome measures
Total morphine milligram equivalents (MMEs) administered in the first 24 hours postoperatively
Time frame: From out of room to 24 hours postoperatively
MMEs will be calculated using the Stanford Opioid Equivalent calculator and data is obtained from the medication administration record (MAR) in epic. Out of room is standard terminology for when the patient leaves the operating room and a required timestamp per standard workflows across all institutions. Two-sided two-sample t-test will be used to compare mean MMEs administered in the first 24 hours between the methadone and control groups. If data is right skewed, log transformation will be performed prior to t-test. If severe violation to normality assumption is detected graphically or by Shapiro-Wilk hypothesis test, Wilcoxon rank-sum test will be performed instead.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
- 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
- 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
- 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)
- Body mass index (BMI) \> 40
- Sleep apnea with an apnea-hypopnea index \> 30 without planned tracheostomy
- Stage 3b chronic kidney disease or higher (estimated glomerular filtration rate \< 45)
- 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
Where
- Portland, Oregon
Collaborators
Oregon Health and Science University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 5, 2026 · Source of record for eligibility and locations