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

NCT06784999 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 21583
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Keywords

head and neck dissection; free flap; sufentanil; methadone

Outcome Measures

Primary Outcomes (1)

• IV morphine equivalent

  Cumulative milligrams IV morphine equivalent

  24 hours

Secondary Outcomes (9)

• Opioid Consumption

  1 hour after arrival time in post anesthesia care unit

• Opioid Consumption

  12 hour after arrival time in post anesthesia care unit

• Opioid Consumption

  24 hour after arrival time in post anesthesia care unit

• Pain Scores

  1 hour after arrival time in post anesthesia care unit

• Pain Scores

  12 hour after arrival time in post anesthesia care unit

Study Arms (2)

Sufentanil

OTHER

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)

Drug: sufentanil

Methadone

OTHER

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)

Drug: methadone

Interventions

sufentanil DRUG

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)

Sufentanil

methadone DRUG

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)

Methadone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Interventions

Sufentanil; Methadone

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ketones; Organic Chemicals

Study Officials

• Gulraj S Chawla, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lyla S Farlow

CONTACT

317-948-9804; lychrist@iu.edu

Angie M Plummer

CONTACT

317-9447239; plummera@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The Primary investigator or his/her designee will inform the anesthesiology team caring for each subject of the am of the study they are in for each case. Subjects and research staff doing post operative assessments will be blinded to the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A total of 128 subjects will be randomized by a computer program into two groups. 1. Intravenous Sufentanil - 0.5 mcg /kg/min ideal body weight N=64 2. Intravenous Methadone - 0.2 mcg/kg ideal body weight max dose of 20mg N=64

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): November 4, 2027
• Study Completion (Estimated): November 4, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)