A Phase 4 interventional study of sufentanil and methadone in Free Flap Reconstruction, sponsored by Indiana University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Indiana University · Phase 4, Interventional, and Treatment
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.
Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients undergoing head and neck dissection with free flap or rotational reconstruction at Indiana University Health Adult Academic Health Center
Exclusion Criteria:
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
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
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)
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)
IV morphine equivalent
Cumulative milligrams IV morphine equivalent
Time frame: 24 hours
Opioid Consumption
Opioid Consumption and morphine equivalent (MME)
Time frame: 1 hour after arrival time in post anesthesia care unit
Opioid Consumption
Opioid Consumption and morphine equivalent (MME)
Time frame: 12 hour after arrival time in post anesthesia care unit
Opioid Consumption
Opioid Consumption and morphine equivalent (MME)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24 hour after arrival time in post anesthesia care unit
Opioid side effect - Nausea
Incident of opioid side effect - Nausea
Time frame: After arrival time to post anesthesia care unit until 24 hrs./completion of study
Opioid side effect - Puritis
Incident of 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
Incident of opioid side effect - Respiratory Depression
Time frame: After arrival time to post anesthesia care unit until 24 hrs./completion of study
Plan to share: No
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