RecruitingPhase 4NCT06784999

Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction

Randomized Prospective Study Comparing Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction


Sponsor

Indiana University

Enrollment

128 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main purpose of this study is to determine which type of medication, sufentanil or methadone, is better at controlling pain during and, more importantly, after surgery in patients undergoing a head and neck dissection with free flap or rotational tissue reconstruction. Prior to their operation, subjects will be randomized to receive either Sufentanil or Methadone. After surgery, research staff will obtain information about recovery and pain levels.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two opioid pain medications — sufentanil (delivered by continuous IV infusion) and methadone (given intravenously) — to determine which one better controls pain during and after head and neck surgery that involves removing tissue and reconstructing the area using a free flap or rotational tissue technique. Patients aged 18–80, classified as low-to-moderate surgical risk (ASA class 1–3), who are scheduled for this specific type of surgery at Indiana University Health are eligible. Before surgery, participants are randomly assigned to one of the two medications, and after surgery, research staff follow up to collect data on pain levels and recovery. Patients with opioid allergies, substance use disorders, home methadone use, or severe liver or kidney disease are not eligible. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGsufentanil

1\. Intravenous sufentanil starting at a dose of 0.5 mcg/kg/min hr ideal body weight (IBW) at the beginning of the case, prior to surgical incision, with a discontinuation of the infusion when the surgical microscope is removed from the patient field and the closure of the incision(s) begins. (n=64)

DRUGmethadone

2\. Intravenous methadone of 0.2 mg/kg IBW up to a maximum dose of 20mg, rounded to the nearest milligram. The methadone will be given at the beginning of the case, prior to surgical incision. n=64)


Locations(1)

Indiana University

Indianapolis, Indiana, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06784999


Related Trials