---
title: Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction
nct_id: NCT06784999
overall_status: RECRUITING
phase: PHASE4
sponsor: Indiana University
study_type: INTERVENTIONAL
primary_condition: Free Flap Reconstruction
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06784999.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06784999"
ct_last_update_post_date: 2026-05-01
last_seen_at: "2026-05-12T07:24:41.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction

**Official Title:** Randomized Prospective Study Comparing Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction

**NCT ID:** [NCT06784999](https://clinicaltrials.gov/study/NCT06784999)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 128
- **Lead Sponsor:** Indiana University
- **Conditions:** Free Flap Reconstruction
- **Start Date:** 2025-01-10
- **Completion Date:** 2027-11-04
- **CT.gov Last Update:** 2026-05-01

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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)
- **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)

## 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)
- **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)

## Primary Outcomes

- **IV morphine equivalent** _(time frame: 24 hours)_ — Cumulative milligrams IV morphine equivalent

## Secondary Outcomes

- **Opioid Consumption** _(time frame: 1 hour after arrival time in post anesthesia care unit)_
- **Opioid Consumption** _(time frame: 12 hour after arrival time in post anesthesia care unit)_
- **Opioid Consumption** _(time frame: 24 hour after arrival time in post anesthesia care unit)_
- **Pain Scores** _(time frame: 1 hour after arrival time in post anesthesia care unit)_
- **Pain Scores** _(time frame: 12 hour after arrival time in post anesthesia care unit)_
- **Pain Scores** _(time frame: 24 hour after arrival time in post anesthesia care unit)_
- **Opioid side effect - Nausea** _(time frame: After arrival time to post anesthesia care unit until 24 hrs./completion of study)_
- **Opioid side effect - Puritis** _(time frame: After arrival time to post anesthesia care unit until 24 hrs./completion of study)_
- **Opioid side effect - Respiratory Depression** _(time frame: After arrival time to post anesthesia care unit until 24 hrs./completion of study)_

## Locations (1)

- Indiana University, Indianapolis, Indiana, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.indiana university|indianapolis|indiana|united states` — added _(2026-05-12)_

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*Canonical: https://parkinsonspathways.com/agent/trials/NCT06784999.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06784999*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*