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

NCT04176419 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: CASE6319
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain Control; Opioid Consumption

Keywords

Head & neck cancer; Microvascular free flap reconstruction

Outcome Measures

Primary Outcomes (2)

• Total opioid consumption measured in daily morphine equivalent

  Total opioid consumption measured in daily morphine equivalent

  at 48 hours postop

• Pain levels on Visual Analog Scale (VAS)

  Change in pain levels on Visual Analog Scale (VAS 0-100mm scale with higher scores corresponding to more pain)

  Pre-Op, 24 hours postop, and 48 hours postop

Secondary Outcomes (3)

• Average Opioid Related Symptom Distress Scale (ORSDS) scores

  at 96 hours after surgery, and at discharge (an average of 1 week)

• Average Patient satisfaction with pain management scores

  at the time of discharge (an average of 1 week)

• Time to first flatulence and defecation

  an average of 7 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

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

Control Group

PLACEBO COMPARATOR

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.

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

Interventions

Ketamine DRUG

0.25 mg/kg IV bolus before incision, followed by 0.005 mg/kg/minute IV for the remainder of the surgical case excluding the final 30-45 minutes.

Also known as: Ketamine Hydrochloride, Ketamine Hydrochloride Injection, USP

Treatment Group

Placebo Ketamine DRUG

0.25 mg/kg IV bolus before incision, followed by 0.005 mg/kg/minute IV for the remainder of the surgical case excluding the final 30-45 minutes.

Control Group

Lidocaine DRUG

1.5 mg/kg IV bolus before incision, followed by infusion of 1.5 mg/kg/hour ideal body weight (max 8 hours) during the case

Also known as: Lidocaine Hydrochloride and 5% dextrose, lidocaine hydrochloride injection

Treatment Group

Placebo Lidocaine DRUG

1.5 mg/kg IV bolus before incision, followed by infusion of 1.5 mg/kg/hour ideal body weight (max 8 hours) during the case

Control Group

Acetaminophen DRUG

1,000 mg orally at time of check-in to the preoperative unit

Also known as: Paracetamol, Tylenol, N-acetyl-para-aminophenol, APAP

Treatment Group

Placebo Acetaminophen DRUG

1,000 mg orally at time of check-in to the preoperative unit

Control Group

Gabapentin DRUG

600 mg orally at time of check in to the preoperative unit

Also known as: Neurontin

Treatment Group

Placebo Gabapentin DRUG

600 mg orally at time of check in to the preoperative unit

Control Group

Celecoxib DRUG

200 mg orally at time of check in to the preoperative unit

Also known as: Celebrex

Treatment Group

Placebo Celecoxib DRUG

200 mg orally at time of check in to the preoperative unit

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Ketamine; Lidocaine; Glucose; Acetaminophen; Gabapentin; Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Hexoses; Monosaccharides; Sugars; Carbohydrates; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jamie Ku, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: January 17, 2020
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

US (1)