Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head an
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 ran
| Condition(s) | Free Flap Reconstruction |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 wh |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Indiana University |
| Locations | Indianapolis, Indiana, United States |
| Start date | 2025-01-10 |
| NCT ID | NCT06784999 |
| Official listing | https://clinicaltrials.gov/study/NCT06784999 |