Recruiting

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

Sponsor:

Indiana University

Code:

NCT06784999

Conditions

Free Flap Reconstruction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

sufentanil

methadone

Study Details

Brief 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.

Conditions

Free Flap Reconstruction

Study ID

NCT06784999

Start date

Jan 10, 2025

Status verified date

Apr, 2026

Completion date

Nov 4, 2027

Anticipated

Primary completion date

Nov 4, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Sufentanil

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)

other: Methadone

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)

Interventions

sufentanil

methadone

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)

Primary outcome measure

IV morphine equivalent [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Lyla S Farlow

317-948-9804 lychrist@iu.edu

Angie M Plummer

317-9447239 plummera@iu.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Lyla S Farlow

317-944-9804 lychrist@iu.edu

Angie M Plummere

317-944-7239 plummera@iu.edu

Principal Investigator:

Gulraj S Chawla, MD

More Information

Sponsor

Indiana University

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

head and neck dissection
free flap
sufentanil
methadone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-01.