Home › NCT06784999

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

Who can join

Ages 18 to 80 · All sexes

Inclusion 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

Exclusion Criteria:

* 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

About the study

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.

What is being tested

• sufentanil (drug)
• methadone (drug)

Sponsor: Indiana University · Participants: 128 · Started: Jan 10, 2025

Contact the study team

• Lyla S Farlow · Phone: 317-948-9804
• Angie M Plummer · Phone: 317-9447239

Official record on ClinicalTrials.gov — NCT06784999

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.