Randomized prospective study comparing sufentanil infusion vs intravenous methadone for postoperative analgesia following head and neck dissection with free flap reconstruction
Gulraj Singh Chawla
Primary Investigator
Brief description of study
What is the purpose of this study?
At Indiana University AAHC, both sufentanil and intravenous methadone are the standard of care for pain management in patients undergoing neck dissection with free flap reconstruction and both have had great success. In this study, we propose to compare their effectiveness at different post-operative time intervals.
THIS STUDY IS ENROLLING BY INVITATION ONLY - All neck and face dissection with free flap tissue reconstruction cases scheduled by otolaryngology surgeons at IU Health University or Methodist Hospital will be identified by research personnel using medical records. Patients will contacted via phone in the week prior to their procedure to gauge interest in the research.
Detailed description of study
What will happen during the study?
Participants will be randomized (by chance, like flipping a coin) into one of the two treatment groups. Both of these treatments are considered standard of care and safe.
Group 1 will receive an infusion of sufentanil (a pain medication) throughout the case and will stopped at a pre-determined time.>
Group 2 will receive Intravenous (in the vein) Methadone (a pain medication). Those randomized to the intravenous methadone (IVM) arm will be induced with general anesthesia in the operating room. The patient will receive the intravenous methadone. The patient will receive the intravenous methadone prior to skin incision.
After the procedure, research staff will record information about participant's recovery and hospital stay. These assessments will be performed at regular intervals for 24 hours after the procedure.
Participants will be in this study from the time of enrollment through about 24 hours after surgery has ended.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: all
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Age: 18 years - 80 years
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Gender: All
Inclusion criteria:
- Patients undergoing head and neck dissection with free flap 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
