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

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.

Conditions

Free Flap Reconstruction

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Free Flap Reconstruction
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * • Patients undergoing head and neck dissection with free flap or rotational reconstruction at Indiana University Health Adult Academic Health Center
  • * ASA class 1, 2, or 3 (See Appendix)
  • * Age 18 to 80
  • * male or female
  • * Able and willing to provide written informed consent
  • * Any contraindication to opiates, (i.e. allergy to opioids, substance use disorder) as determined by PI review and any contraindications reported by the patient
  • * Patient on home methadone at any dose
  • * Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery
  • * Known true allergy to the study medications (sufentanil, methadone)
  • * Any history of substance abuse in the past 6 months which would include heroin or any other illegal street drugs
  • * End stage liver disease, end stage renal disease
  • * Patient staying intubated or on mechanical ventilation after surgery
  • * Patient (home dose) taking more than 30mg PO morphine equivalent (OME) per day
  • * Any additional and concurrent surgical procedures to the patient

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Gulraj S Chawla, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

2027-11-04