Clinical trial NCT06784999: Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Free Flap Reconstruction
Keywords: head and neck dissection
free flap
sufentanil
methadone
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: IV morphine equivalent
timeFrame: 24 hours
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 1 hour after arrival time in post anesthesia care unit
measure: Opioid Consumption
timeFrame: 12 hour after arrival time in post anesthesia care unit
measure: Opioid Consumption
timeFrame: 24 hour after arrival time in post anesthesia care unit
measure: Pain Scores
timeFrame: 1 hour after arrival time in post anesthesia care unit
measure: Pain Scores
timeFrame: 12 hour after arrival time in post anesthesia care unit
measure: Pain Scores
timeFrame: 24 hour after arrival time in post anesthesia care unit
measure: Opioid side effect - Nausea
timeFrame: After arrival time to post anesthesia care unit until 24 hrs./completion of study
measure: Opioid side effect - Puritis
timeFrame: After arrival time to post anesthesia care unit until 24 hrs./completion of study
measure: Opioid side effect - Respiratory Depression
timeFrame: After arrival time to post anesthesia care unit until 24 hrs./completion of study
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Gulraj S Chawla, MD
role: PRINCIPAL_INVESTIGATOR
References: