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

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.

Study Overview

• Status: Recruiting
• Conditions: Free Flap Reconstruction
• Intervention / Treatment: Drug: sufentanil; Drug: methadone

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lyla S Farlow; Phone Number: 317-948-9804; Email: lychrist@iu.edu
• Study Contact Backup: Name: Angie M Plummer; Phone Number: 317-9447239; Email: plummera@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
      • Contact: Lyla S Farlow; Phone Number: 317-944-9804; Email: lychrist@iu.edu
      • Contact: Angie M Plummere; Phone Number: 317-944-7239; Email: plummera@iu.edu
      • Principal Investigator: Gulraj S Chawla, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Drug: 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)	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IV morphine equivalent	Cumulative milligrams IV morphine equivalent	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Opioid Consumption and morphine equivalent (MME)	1 hour after arrival time in post anesthesia care unit
Opioid Consumption	Opioid Consumption and morphine equivalent (MME)	12 hour after arrival time in post anesthesia care unit
Opioid Consumption	Opioid Consumption and morphine equivalent (MME)	24 hour after arrival time in post anesthesia care unit
Pain Scores	Visual analog scale (VAS) pain score on a scale of 1-10 (increments of 1 unit), 1 being no pain at all and 10 being the most pain the patient has ever experienced	1 hour after arrival time in post anesthesia care unit
Pain Scores	Visual analog scale (VAS) pain score on a scale of 1-10 (increments of 1 unit), 1 being no pain at all and 10 being the most pain the patient has ever experienced	12 hour after arrival time in post anesthesia care unit
Pain Scores	Visual analog scale (VAS) pain score on a scale of 1-10 (increments of 1 unit), 1 being no pain at all and 10 being the most pain the patient has ever experienced	24 hour after arrival time in post anesthesia care unit
Opioid side effect - Nausea	Incident of opioid side effect - Nausea	After arrival time to post anesthesia care unit until 24 hrs./completion of study
Opioid side effect - Puritis	Incident of opioid side effect - Puritis	After arrival time to post anesthesia care unit until 24 hrs./completion of study
Opioid side effect - Respiratory Depression	Incident of opioid side effect - Respiratory Depression	After arrival time to post anesthesia care unit until 24 hrs./completion of study

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Gulraj S Chawla, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): November 4, 2027
• Study Completion (Estimated): November 4, 2027

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sufentanil; methadone; free flap; head and neck dissection
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Ketones; Fentanyl; Methadone; Sufentanil
• Other Study ID Numbers: 21583

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes