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

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Active, not recruiting; Phase 3

Conditions: Opioid Consumption; Postoperative Pain Control

Treatments: Drug: Placebo Lidocaine; Drug: Placebo Ketamine; Drug: Celecoxib; Drug: Placebo Acetaminophen; Drug: Placebo Celecoxib; Drug: Ketamine; Drug: Gabapentin; Drug: Placebo Gabapentin; Drug: Lidocaine; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT04176419

CASE6319

Details and patient eligibility

About

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.

Full description

This study will help the study team determine how the experimental, non-opioid pain control regimen affects opioid-related side effects, participant satisfaction with pain management, PACU length of stay, hospital length of stay, chronic pain level, and chronic pain-related disability in participants, and to determine the safety and tolerability of the non-opioid pain control regimen in head and neck cancer patients undergoing cancer surgery with free flap reconstruction. Ketamine, Lidocaine, Acetaminophen, Gabapentin, and Celecoxib are FDA-approved drugs that have been approved for use individually, and have been used in combination for perioperative pain control. However, the use of these five drugs together in head and neck cancer patients undergoing free flap reconstruction has not been studied, which is why this study is experimental.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

Perioperative intervention (preoperative acetaminophen, gabapentin, and celecoxib and intraoperative ketamine and lidocaine). The Investigational Drug Service will mix and prepare the study medications necessary for each participant. An Investigational Drug Service staff member will deliver the oral medications to the nursing team in the preoperative holding unit and the IV medications to the anesthesia team in the OR unit.

Treatment:

Drug: Acetaminophen

Drug: Gabapentin

Drug: Lidocaine

Drug: Ketamine

Drug: Celecoxib

Control Group

Placebo Comparator group

Description:

Perioperative placebo Placebo oral drugs will be encapsulated versions provided by the Investigational Drug Service and will appear identical to the interventional oral drugs. Placebo IV infusions will be prepared by Investigational Drug Service as per institutional guidelines and will appear identical to the interventional IV drugs.

Treatment:

Drug: Placebo Gabapentin

Drug: Placebo Celecoxib

Drug: Placebo Acetaminophen

Drug: Placebo Ketamine

Drug: Placebo Lidocaine