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

Summary

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.

Detailed Description

PRIMARY OBJECTIVE: I. To assess the effectiveness of intraoperative methadone compared to control in reducing the requirements of morphine milliequivalents (MMEs). SECONDARY OBJECTIVES: I. To assess the effectiveness of intraoperative methadone compared to control in reducing objective measures of pain, including MMEs, for up to 72 hours postoperatively. II. To assess how soon after surgery patients require additional opioid administration for those in the methadone group compared to control. III. To assess whether additional pain management is required less frequently in the methadone group compared to control. EXPLORATORY OBJECTIVES: I. To assess if there is an increase in the incidence of post-operative emesis events in the methadone group compared to the control. II. To assess the effectiveness of intraoperative methadone compared to control on patient's pain scores daily. III. To assess whether there is a difference in respiratory status between the methadone group compared to the control. IV. To assess whether higher rates of naloxone administration are required in the methadone group. V. To assess if pain control impacted acute recovery more effectively in the methadone group compared to control. VI. Clinical outcomes that are standard of care may be assessed. VII. To assess if there is any impact on pain at \~1 month postoperatively compared to the control group. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive methadone intravenously (IV) at the time of incision during standard of care (SOC) surgery. Patients also receive SOC fentanyl prior to SOC laryngoscopy procedure. ARM II: Patients receive SOC fentanyl prior to SOC laryngoscopy procedure and surgery. After completion of study intervention, patients are followed up at 4-6 weeks.

Eligibility Criteria

Interventions