This phase III trial studies how well a non-opioid pain control regimen administered before and during surgery works for pain management in patients undergoing head and neck cancer surgery. Opioids are a class of drugs that work in the brain to produce a variety of effects, including pain relief. In addition to controlling pain, opioids can make some people feel "high" and can be addictive. Acetaminophen, celecoxib, gabapentin, ketamine and lidocaine are non-opioid medications that when given before and during surgery, may improve post-surgery pain and/or decrease opioid consumption, which may relieve opioid related side effects and adverse symptoms, improve quality of life, and decrease the risk of chronic pain.
Additional locations may be listed on ClinicalTrials.gov for NCT04176419.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Total opioid consumption (daily morphine equivalent) at 48 hours post-operation (postop).
II. Pain levels on Visual Analog Scale (VAS) at 48 hours post-operation (postop).
SECONDARY OBJECTIVES:
I. Opioid Related Symptom Distress Scale (ORSDS) questionnaire (at 96 hours after surgery as well as at discharge).
II. Internally-developed “patient satisfaction with pain management” questionnaire (at the time of discharge).
III. Time to first defecation from end of surgical case (as noted on operative report in Epic).
EXPLORATORY OBJECTIVES:
I. Post-anesthesia care unit (PACU) length of stay.
II. Hospital length of stay.
III. Quality of recovery.
IV. Head and neck specific quality of life.
V. Chronic pain level.
VI. Chronic pain-related disability.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Before surgery, patients receive acetaminophen orally (PO), celecoxib PO, and gabapentin PO. During surgery, patients receive ketamine hydrochloride intravenously (IV) before incision up to 45 minutes before the end of surgery, and lidocaine hydrochloride IV for a maximum of 8 hours.
GROUP II: Before surgery, patients receive placebo acetaminophen PO, placebo celecoxib PO, and placebo gabapentin PO. During surgery, patients receive placebo ketamine hydrochloride IV before incision up to 45 minutes before the end of surgery, and placebo lidocaine hydrochloride IV for a maximum of 8 hours.
After the end of study, patients are followed up to 6 months.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorJamie Ahn Ku
