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NCT Number: NCT06784999

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.

Recruiting

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Key information

Conditions

Free Flap Reconstruction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil

Drug
  • 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
  • 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

  1. IV morphine equivalent

    Time frame: 24 hours

    Cumulative milligrams IV morphine equivalent

Secondary outcomes

  1. Opioid Consumption

    Time frame: 1 hour after arrival time in post anesthesia care unit

    Opioid Consumption and morphine equivalent (MME)

  2. Opioid Consumption

    Time frame: 12 hour after arrival time in post anesthesia care unit

    Opioid Consumption and morphine equivalent (MME)

  3. Opioid Consumption

    Time frame: 24 hour after arrival time in post anesthesia care unit

    Opioid Consumption and morphine equivalent (MME)

  4. Pain Scores

    Time frame: 1 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

  5. Pain Scores

    Time frame: 12 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

  6. Pain Scores

    Time frame: 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

  7. Opioid side effect - Nausea

    Time frame: After arrival time to post anesthesia care unit until 24 hrs./completion of study

    Incident of opioid side effect - Nausea

  8. Opioid side effect - Puritis

    Time frame: After arrival time to post anesthesia care unit until 24 hrs./completion of study

    Incident of opioid side effect - Puritis

  9. Opioid side effect - Respiratory Depression

    Time frame: After arrival time to post anesthesia care unit until 24 hrs./completion of study

    Incident of opioid side effect - Respiratory Depression

Study contacts

Contact information is provided by the study sponsor or research team.

Angie M Plummer

CONTACT

[email protected]

317-9447239

Lyla S Farlow

CONTACT

[email protected]

317-948-9804

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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