Intraoperative Methadone for the Management of Postoperative Pain in Patients With Head and Neck Cancers

NCT ID
NCT07857655
Registry status
Recruiting
Study type
Interventional
Phase
Phase 4
Sponsor
OHSU Knight Cancer Institute
Conditions
Head and Neck Carcinoma, Hypopharyngeal Carcinoma, Laryngeal Carcinoma, Oral Cavity Carcinoma, Oropharyngeal Carcinoma

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Intraoperative Methadone for Postoperative Pain Management in a Head and Neck Oncology Population - A Prospective, Randomized Controlled Trial

Enrollment: 58 participants (Estimated).

What is being studied

  • Intervention: Diagnosis
  • Intervention: Diagnostic Techniques and Procedures
  • Intervention: Diagnostic Techniques, Respiratory System
  • Intervention: Diagnostic Techniques, Surgical
  • Other: Electronic Health Record Review
  • Intervention: Endoscopy
  • Intervention: Fentanyl
  • Drug: Fentanyl
  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 1-Ring
  • Intervention: Ketones
  • Device: Laryngoscopy
  • Intervention: Laryngoscopy
  • Drug: Methadone
  • Intervention: Methadone
  • Intervention: Minimally Invasive Surgical Procedures
  • Intervention: Organic Chemicals
  • Intervention: Otorhinolaryngologic Surgical Procedures
  • Intervention: Piperidines
  • Procedure: Surgical Procedure
  • Intervention: Surgical Procedures, Operative
  • Other: Survey Administration

Who may be eligible

Ages
18 Years to 89 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Oregon, United States: 1

Sample of listed locations

  • OHSU Knight Cancer Institute — Portland, Oregon, 97239, United States — Recruiting

Study details

Start date
September 22, 2026
Primary completion date
July 29, 2029
Completion date
July 29, 2029
First posted
October 5, 2026
Collaborators
Oregon Health and Science University

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07857655
Registry last updated
October 5, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07857655 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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