This phase III trial compares methadone to standard pain medications during spinal surgery in managing pain. Managing pain levels for the first 72 hours after surgery is very important. Poor pain management can lead to severe pain (both in the short term and the long term), and it can cause people to have a difficult time recovering both physically and mentally. Methadone is a pain medication that lasts longer than other medications and is sometimes used after surgery as part of standard care. It is a type of drug called an opioid. This means it targets a protein found on cells called the ì-opioid receptor. This receptor helps control pain in the body. By targeting this receptor, methadone helps lessen pain. Giving methadone during surgery may help control pain after surgery and reduce the need for other pain medications.
Additional locations may be listed on ClinicalTrials.gov for NCT05417100.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the utility of intraoperative methadone used in reducing perioperative opioid consumption measured as morphine equivalents after arrival to post-anesthesia care unit (PACU) until postoperative day 3 (POD3) (72 hours [hr.] post-surgery).
SECONDARY OBJECTIVES:
I. To assess acute post-operative pain measured using numerical rating scale (NRS) pain scores at rest.
II. To assess the dose of rescue analgesia (hydromorphone) from extubation to PACU arrival.
III. To assess intraoperative opioid consumption (remifentanil) on a per hour basis.
IV. To assess while in PACU/neuro observation unit (NOU) incidence of hypoventilation (respiratory rate < 8 and/or pulse oximetry reading of < 90% for greater than 2 minute [min]).
V. To assess the inability to extubate the trachea in the operating room/ length of post-op ventilation/intubation.
VI. To assess the total dose of dexmedetomidine administered between the two groups.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive methadone intravenously (IV) during surgery.
ARM II: Patients do not receive methadone during surgery.
After completion of study treatment, patients are followed up at 3 weeks, 3 months, and 6 months after surgery.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJess W. Brallier
