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

NCT ID: NCT06784999

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2027-11-04

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.

Conditions

Free Flap Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sufentanil

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)

Group Type: OTHER

sufentanil

Intervention Type: DRUG

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)

Methadone

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)

Group Type: OTHER

methadone

Intervention Type: DRUG

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)

Interventions

sufentanil

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)

Intervention Type: DRUG

methadone

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)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Gulraj Chawla

MD, Assistant Professor of Clinical Anesthesia Program Director, Regional Anesthesia and Acute Pain Medicine Fellowship

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulraj S Chawla, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lyla S Farlow

Role: CONTACT

lychrist@iu.edu

317-948-9804

Angie M Plummer

Role: CONTACT

plummera@iu.edu

317-9447239

Facility Contacts

Lyla S Farlow

Role: primary

lychrist@iu.edu

317-944-9804

Angie M Plummere

Role: backup

plummera@iu.edu

317-944-7239

Other Identifiers

21583

Identifier Type: -

Identifier Source: org_study_id