Randomized prospective study comparing sufentanil infusion vs intravenous methadone for postoperative analgesia following head and neck dissection with free flap reconstruction
Pain Relief Study After Head and Neck Surgery
Gulraj Singh Chawla
Primary Investigator
Brief description of 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. 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.
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
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: Head and neck surgery with free flap reconstruction
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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
This study investigates the effectiveness of two pain medications, sufentanil and methadone, in managing pain for patients undergoing head and neck dissection with tissue reconstruction. Head and neck dissection is a surgical procedure where parts of the head or neck are removed, and tissue reconstruction is when tissue is moved to the area to help heal. The purpose of this study is to find out which medication is better at controlling pain after surgery.
Participants in this study will be randomly assigned to one of two study arms. One arm will receive an infusion of sufentanil, a pain medication, during the surgery. The other arm will receive intravenous methadone, another pain medication, before the surgery starts. After the surgery, researchers will monitor recovery and pain levels for 24 hours to gather information about how well each medication works.
- Who can participate: Adults aged 18 to 80 having head and neck surgery with tissue reconstruction at Indiana University Health can join. They must give written consent and not have issues with opioids or a history of substance abuse.
- Study details: Participants will be randomly assigned to receive either sufentanil or methadone. Sufentanil will be given through an infusion during surgery, while methadone will be administered intravenously before surgery starts. Researchers will collect data on recovery and pain levels for 24 hours post-surgery.
- Study timelines: The study will last 24 hours after surgery.
