Details

Details

Title A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Investigate the Effect of a Perioperative Analgesia Protocol on Postoperative Opioid Usage and Pain Control in Patients Undergoing Major Head and Neck Cancer Surgery Requiring Microvascular Free Flap Reconstruction

IRB CASE6319

CC 19-1203

Hospital Main Campus

Phase Phase 3

Disease Head and Neck

Drug Acetaminophen , Celecoxib , Gabapentin , Lidocaine

Description

Description

Primary Objective
  • Total opioid consumption (daily morphine equivalent) at 48 hours postop
  • Pain levels on Visual Analog Scale (VAS) at 48 hours postop
Secondary Objective(s)
  • Opioid Related Symptom Distress Scale (ORSDS) questionnaire (at 96 hours after surgery as well as at discharge)
  • Internally-developed "patient satisfaction with pain management" questionnaire (at the time of discharge)
  • Time to first defecation
Exploratory Objective(s)
  • PACU length of stay
  • Hospital length of stay
  • Quality of recovery
  • Head and neck specific quality of life
  • Chronic pain level
  • Chronic pain-related disability
Inclusion Criteria

Inclusion Criteria

  1. Age ≥18 years (As pediatric oncologic free flap procedures are rare, children are excluded from this study.)
  2. Undergoing head & neck free flap reconstruction at the Cleveland Clinic Main Campus
  3. Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria

Exclusion Criteria

  1. History of allergy to lidocaine, ketamine, acetaminophen, gabapentin, and/or celecoxib
  2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ketamine, Lidocaine or other agents used in this study
  3. Subjects receiving any other investigational agents
  4. Inadequate renal function (serum creatinine ≥ 2 mg/dl) within 30 days
  5. Inadequate hepatic function (total bilirubin ≥ 2 x the institutional ULN and/or AST or ALT ≥3 x the institutional ULN) within 30 days
  6. Known or suspected history of illicit drug abuse (including opioids but excluding tobacco and EtOH) within the past 6 months
  7. Pregnancy
  8. Contraindication to lidocaine (heart block, heart failure with EF < 30%) as determined by history of Congestive Heart Failure, or as determined by preoperative evaluation for surgical clearance
  9. 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