RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-10
Study Completion:2027-11-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06784999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Patients undergoing head and neck dissection with free flap or rotational reconstruction at Indiana University Health Adult Academic Health Center
  2. * ASA class 1, 2, or 3 (See Appendix)
  3. * Age 18 to 80
  4. * male or female
  5. * Able and willing to provide written informed consent
  1. * Any contraindication to opiates, (i.e. allergy to opioids, substance use disorder) as determined by PI review and any contraindications reported by the patient
  2. * Patient on home methadone at any dose
  3. * Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery
  4. * Known true allergy to the study medications (sufentanil, methadone)
  5. * Any history of substance abuse in the past 6 months which would include heroin or any other illegal street drugs
  6. * End stage liver disease, end stage renal disease
  7. * Patient staying intubated or on mechanical ventilation after surgery
  8. * Patient (home dose) taking more than 30mg PO morphine equivalent (OME) per day
  9. * Any additional and concurrent surgical procedures to the patient

Contacts and Locations

Study Contact

Lyla S Farlow
CONTACT
317-948-9804
lychrist@iu.edu
Angie M Plummer
CONTACT
317-9447239
plummera@iu.edu

Principal Investigator

Gulraj S Chawla, MD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Indiana University
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Gulraj S Chawla, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-10
Study Completion Date2027-11-04

Study Record Updates

Study Start Date2025-01-10
Study Completion Date2027-11-04

Terms related to this study

Keywords Provided by Researchers

  • head and neck dissection
  • free flap
  • sufentanil
  • methadone

Additional Relevant MeSH Terms

  • Free Flap Reconstruction