Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine how a non-opioid pain control regimen, administered before and during surgery, will affect postoperative pain control and total opioid consumption in head and neck cancer participants undergoing cancer surgery with free flap reconstruction.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Treatments: Acetaminophen; Celecoxib; Gabapentin; Ketamine; Lidocaine

Criteria

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

• Inadequate renal function (serum creatinine ≥ 2 mg/dl) within 30 days

• Inadequate hepatic function (total bilirubin ≥ 2 x the institutional ULN and/or AST or ALT ≥3 x the institutional ULN) within 30 days

• Known or suspected history of illicit drug abuse (including opioids but excluding tobacco and EtOH) within the past 6 months

• Pregnancy

• 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

• 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