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.
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
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)
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
Parallel
Electronic Health Record Review
Other interventionAncillary studies
Fentanyl
DrugGiven SOC fentanyl
Laryngoscopy
DeviceUndergo SOC laryngoscopy
Methadone
DrugGiven IV
Surgical Procedure
Procedure/SurgeryUndergo SOC surgery
Survey Administration
Other interventionAncillary studies
Total morphine milligram equivalents (MMEs) administered in the first 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.
Cumulative MMEs between 24-48 hours postoperatively and 48-72 hours postoperatively
Will be analyzed as the same approaches as the primary endpoint with two-sided two-sample t-test. 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.
Time to first dose of oral opioid administered & intravenous opioid administered
Will be assessed using a time-to-event analysis (log-rank test) to compare between the two groups.
Acute pain service (APS) consult placement (Yes/No) and outcome of that consult
Chi-squared test (or Fisher's exact test if any expected count is \< 5) will be used to compare proportion of APS placement between the two groups. Chi-squared test (or Fisher's exact test if any expected count is \< 5) will be used to assess the ambulatory goals comparing the proportion of goals achieved between the two groups on each post-operative day (POD) period. (POD0, POD1 and POD2).
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OHSU Knight Cancer Institute
Lead sponsor
Oregon Health and Science University
Collaborator
