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

Indiana University

Status and phase: Enrolling; Phase 4

Conditions: Free Flap Reconstruction

Treatments: Drug: sufentanil; Drug: methadone

Study type: Interventional

Funder types: Other

Identifiers

NCT06784999

21583

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

Sufentanil

Other group

Description:

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)

Treatment:

Drug: sufentanil

Methadone

Other group

Description:

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)

Treatment:

Drug: methadone