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.
• 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
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)
Parallel
sufentanil
Drug1\. 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
Drug2\. 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
Opioid Consumption
Opioid Consumption and morphine equivalent (MME)
Opioid Consumption
Opioid Consumption and morphine equivalent (MME)
Opioid Consumption
Opioid Consumption and morphine equivalent (MME)
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
Click on the lead sponsor to view all of their trials.
