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

StatusRecruiting
PhasePhase 4
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07857655
Lead Sponsor OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University
Conditions
(from sponsor)
Head and Neck Carcinoma, Hypopharyngeal Carcinoma, Laryngeal Carcinoma, Oral Cavity Carcinoma, Oropharyngeal Carcinoma
Related terms Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Oropharyngeal Neoplasms
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov