Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07857655
PHASE4

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

Sponsor: OHSU Knight Cancer Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2026-09-22

Completion Date

2029-07-29

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

OTHER

Electronic Health Record Review

Ancillary studies

DRUG

Fentanyl

Given SOC fentanyl

DEVICE

Laryngoscopy

Undergo SOC laryngoscopy

DRUG

Methadone

Given IV

PROCEDURE

Surgical Procedure

Undergo SOC surgery

OTHER

Survey Administration

Ancillary studies

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States