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A Non-opioid Pain Control Regimen for Pain Management in Patients Undergoing Head and Neck Cancer Surgery

Trial Status: Active

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.

Inclusion Criteria

  • Undergoing head & neck free flap reconstruction at the Cleveland Clinic main campus
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • History of allergy to lidocaine, ketamine, acetaminophen, gabapentin, and/or celecoxib
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ketamine, lidocaine or other agents used in this study
  • Subjects receiving any other investigational agents
  • Serum creatinine >= 2 mg/dl within 30 days
  • Total bilirubin >= 2 X the institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 3 X the institutional ULN within 30 days
  • Known or suspected history of illicit drug abuse (including opioids but excluding tobacco and ethanol [EtOH]) within the past 6 months
  • Pregnancy
  • Contraindication to lidocaine (heart block, heart failure with ejection fraction [EF] < 30%) as determined by history of congestive heart failure, or as determined by preoperative evaluation for surgical clearance
  • In the opinion of the investigator, subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements


Case Comprehensive Cancer Center
Status: ACTIVE
Contact: Jamie Ku
Phone: 216-445-6594


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).


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).


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 Phase Phase III

Trial Type Supportive care

Lead Organization
Case Comprehensive Cancer Center

Principal Investigator
Jamie Ku

  • Primary ID CASE6319
  • Secondary IDs NCI-2020-00497
  • ID NCT04176419