Free Flap ReconstructionPhase 4NCT06784999
Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction
A Phase 4 study testing sufentanil and methadone in people with Free Flap Reconstruction, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Free Flap Reconstruction
- What is being tested?
- sufentanil and methadone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2025to 4 Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Lyla S Farlow, 317-944-9804, lychrist@iu.edu
Angie M Plummere, 317-944-7239, plummera@iu.edu
About this study
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
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
- Being tested
- sufentanil, methadone
- Keywords
- head and neck dissection, free flap, sufentanil, methadone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sufentanilDrug
- 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)
methadoneDrug
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
IV morphine equivalent
Cumulative milligrams IV morphine equivalent
Measured: 24 hours
Secondary outcomes (9)
Opioid Consumption
Opioid Consumption and morphine equivalent (MME)
Measured: 1 hour after arrival time in post anesthesia care unit
Opioid Consumption
Opioid Consumption and morphine equivalent (MME)
Measured: 12 hour after arrival time in post anesthesia care unit
Opioid Consumption
Opioid Consumption and morphine equivalent (MME)
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hour after arrival time in post anesthesia care unit
Opioid side effect - Nausea
Incident of opioid side effect - Nausea
Measured: After arrival time to post anesthesia care unit until 24 hrs./completion of study
Opioid side effect - Puritis
Incident of opioid side effect - Puritis
Measured: 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
Measured: After arrival time to post anesthesia care unit until 24 hrs./completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start10 Jan 2025
- Primary completion4 Nov 2027 (estimated)
- Study completion4 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Flap ReconstructionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jyoti Pankaj Dangle, Indiana University
- Investigators
- Gulraj S Chawla, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784999
- Sponsor's protocol ID
- 21583
- Status last verified
- Apr 2026
- First submitted
- 15 Jan 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06784999
- Acronym / sponsor ID
- 21583
- Conditions
- Free Flap Reconstruction
- Keywords
- head and neck dissection, free flap, sufentanil, methadone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 4 Nov 2027 (estimated)
- Study completion
- 4 Nov 2027 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Sufentanil | Other | Drug: sufentanil1. 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 | Drug: methadone2. 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients undergoing head and neck dissection with free flap or rotational reconstruction at Indiana University Health Adult Academic Health Center
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sufentanil1. 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 |
| methadone2. 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 |
Primary outcome
IV morphine equivalent
Time frame: 24 hours
Cumulative milligrams IV morphine equivalent
9 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gulraj S Chawla, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sufentanil and methadone in people with Free Flap Reconstruction, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lyla S Farlow (317-948-9804, lychrist@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IV morphine equivalent (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.