OncoMatch/Clinical Trials/NCT07857655
Intraoperative Methadone for the Management of Postoperative Pain in Patients With Head and Neck Cancers
Official title: Intraoperative Methadone for Postoperative Pain Management in a Head and Neck Oncology Population - A Prospective, Randomized Controlled Trial
Is NCT07857655 recruiting? Yes, currently enrolling (Oct 2026). This Phase 4 trial studies multiple treatments including Fentanyl and Laryngoscopy for head and neck carcinoma.
Treatment: Fentanyl · Laryngoscopy · Methadone — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Demographics
Prior therapy
Cannot have received: long-acting opioid
Current use of long-acting opioids
Cannot have received: opioid for non-cancer or chronic pain
Pain patients treated with opioids for pathology unrelated to head and neck cancer and/or chronic pain patients, i.e. chronic back pain
Lab requirements
Kidney function
Stage 3b chronic kidney disease or higher (eGFR < 45) [excluded]
Liver function
AST/ALT greater than two times the upper limit of normal [excluded]
Cardiac function
history of corrected QT interval (QTc) prolongation > 500 ms [excluded]
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- OHSU Knight Cancer Institute · Portland, Oregon
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07857655 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior long-acting opioid, opioid for non-cancer or chronic pain disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 89 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages