Free Flap Reconstruction
Conditions
Keywords
head and neck dissection, free flap, sufentanil, methadone
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.
Interventions
DRUGsufentanil
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)
DRUGmethadone
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)
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The Primary investigator or his/her designee will inform the anesthesiology team caring for each subject of the am of the study they are in for each case. Subjects and research staff doing post operative assessments will be blinded to the randomization.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IV morphine equivalent | 24 hours | Cumulative milligrams IV morphine equivalent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 1 hour after arrival time in post anesthesia care unit | Opioid Consumption and morphine equivalent (MME) |
| Pain Scores | 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 |
| Opioid side effect - Nausea | After arrival time to post anesthesia care unit until 24 hrs./completion of study | Incident of opioid side effect - Nausea |
| Opioid side effect - Puritis | After arrival time to post anesthesia care unit until 24 hrs./completion of study | Incident of opioid side effect - Puritis |
| Opioid side effect - Respiratory Depression | After arrival time to post anesthesia care unit until 24 hrs./completion of study | Incident of opioid side effect - Respiratory Depression |
Countries
United States
Contacts
CONTACTLyla S Farlow
CONTACTAngie M Plummer
PRINCIPAL_INVESTIGATORGulraj S Chawla, MD
Indiana University
Outcome results
None listed