BridgeMD
Compares treatment options for Free Flap Reconstruction
Official title Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction
ClinicalTrials.gov ID: NCT06784999
What this study is testing
What is sufentanil?
sufentanil is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for free flap reconstruction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- Any contraindication to opiates, (i.e. allergy to opioids, substance use disorder) as determined by PI review and any contraindications reported by...
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.