NCT06784999 Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction
| NCT ID | NCT06784999 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Indiana University |
| Condition | Free Flap Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2027-11-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 128 participants in total. It began in 2025-01-10 with a primary completion date of 2027-11-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Gulraj S Chawla, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT06784999 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Free Flap Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06784999 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06784999 currently recruiting?
Yes, NCT06784999 is actively recruiting participants. Contact the research team at lychrist@iu.edu for enrollment information.
Where is the NCT06784999 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT06784999 clinical trial?
NCT06784999 is sponsored by Indiana University. The principal investigator is Gulraj S Chawla, MD at Indiana University. The trial plans to enroll 128 participants.