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

Phase 4

Recruiting

• Conditions: Free Flap Reconstruction
• Interventions: Drug: sufentanil; Drug: methadone

• Registration Number: NCT06784999
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-10
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2027-11-04
• Study Completion: 2027-11-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanil	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)
Methadone	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 Measures

Name	Time	Method
IV morphine equivalent	24 hours	Cumulative milligrams IV morphine equivalent

Secondary Outcome Measures

Name	Time	Method
Opioid side effect - Nausea	After arrival time to post anesthesia care unit until 24 hrs./completion of study	Incident of opioid side effect - Nausea
Pain Scores	24 hour after arrival time in post anesthesia care unit	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
Opioid Consumption	24 hour after arrival time in post anesthesia care unit	Opioid Consumption and morphine equivalent (MME)
Opioid side effect - Puritis	After arrival time to post anesthesia care unit until 24 hrs./completion of study	Incident of opioid side effect - Puritis
Opioid side effect - Respiratory Depression	After arrival time to post anesthesia care unit until 24 hrs./completion of study	Incident of opioid side effect - Respiratory Depression

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States