Comparing sufentanil and methadone for pain relief after head and neck surgery
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
Run by Indiana University · NCT06784999 · Data updated 2026-11-12
This study tests whether sufentanil or methadone works better for managing pain after head and neck surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | January 10, 2025 |
| Main results expected | November 4, 2027 |
| Study ends | November 4, 2027 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT06784999 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 who are scheduled for head and neck dissection with free flap or rotational reconstruction and meet specific health criteria.
✕Probably not a fit
Patients with contraindications to opioids, a history of substance abuse, or those requiring mechanical ventilation post-surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of two pain management medications, sufentanil and methadone, in patients undergoing head and neck dissection with free flap or rotational reconstruction. Participants will be randomly assigned to receive either sufentanil or methadone prior to surgery, and their postoperative pain levels and recovery will be monitored. The goal is to determine which medication provides better analgesia during the recovery period following surgery.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing complex head and neck surgeries.
How similar studies have gone: Previous studies have explored opioid alternatives for postoperative pain management, but this specific comparison of sufentanil and methadone is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Indiana University
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: Gulraj S Chawla, MD — Indiana University
- Study coordinator: Lyla S Farlow
- Email: lychrist@iu.edu
- Phone: 317-948-9804
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.