Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04176419
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : May 13, 2022
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Control Opioid Consumption Drug: Ketamine Drug: Placebo Ketamine Drug: Lidocaine Drug: Placebo Lidocaine Drug: Acetaminophen Drug: Placebo Acetaminophen Drug: Gabapentin Drug: Placebo Gabapentin Drug: Celecoxib Drug: Placebo Celecoxib Phase 3

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Investigating 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
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group

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
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.
Other Names:
  • Ketamine Hydrochloride
  • Ketamine Hydrochloride Injection
  • USP

Drug: Lidocaine
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
Other Names:
  • Lidocaine Hydrochloride and 5% dextrose
  • lidocaine hydrochloride injection

Drug: Acetaminophen
1,000 mg orally at time of check-in to the preoperative unit
Other Names:
  • Paracetamol
  • Tylenol
  • N-acetyl-para-aminophenol
  • APAP

Drug: Gabapentin
600 mg orally at time of check in to the preoperative unit
Other Name: Neurontin

Drug: Celecoxib
200 mg orally at time of check in to the preoperative unit
Other Name: Celebrex

Placebo Comparator: Control Group

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
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.

Drug: Placebo Lidocaine
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

Drug: Placebo Acetaminophen
1,000 mg orally at time of check-in to the preoperative unit

Drug: Placebo Gabapentin
600 mg orally at time of check in to the preoperative unit

Drug: Placebo Celecoxib
200 mg orally at time of check in to the preoperative unit




Primary Outcome Measures :
  1. Total opioid consumption measured in daily morphine equivalent [ Time Frame: at 48 hours postop ]
    Total opioid consumption measured in daily morphine equivalent

  2. Pain levels on Visual Analog Scale (VAS) [ Time Frame: Pre-Op, 24 hours postop, and 48 hours postop ]
    Change in pain levels on Visual Analog Scale (VAS 0-100mm scale with higher scores corresponding to more pain)


Secondary Outcome Measures :
  1. Average Opioid Related Symptom Distress Scale (ORSDS) scores [ Time Frame: at 96 hours after surgery, and at discharge (an average of 1 week) ]

    Average Opioid Related Symptom Distress Scale (ORSDS) scores

    The OR-SDS is used to assess subject-reported levels of severity concerning 12 symptoms known to be associated with opioid medication usage. Symptom frequency, severity, and how bothersome symptom was is rated from 1-4 with higher . The average score for each symptom is calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe).


  2. Average Patient satisfaction with pain management scores [ Time Frame: at the time of discharge (an average of 1 week) ]

    Average scores for Internally-developed "patient satisfaction with pain management" questionnaire.

    Domains include pain expected vs experienced, frequency of severe pain, promptness of care team, effectiveness of treatment, and future preferences

    Domain scores range from 1-5 with higher scores mean worse outcomes (more severe pain, poor quality of care)

    Domains are distinct and are not summarized with a "total"score.


  3. Time to first flatulence and defecation [ Time Frame: an average of 7 days ]
    Time to first flatulence and defecation from end of surgical case



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176419


Contacts
Layout table for location contacts
Contact: Jamie Ku, MD 1-866-223-8100 TaussigResearch@ccf.org

Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jamie Ku, MD    866-223-8100    TaussigResearch@ccf.org   
Contact: Brian Matia    +1 216-445-8748    matiab@ccf.org   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Jamie Ku, MD Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04176419    
Other Study ID Numbers: CASE6319
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Case Comprehensive Cancer Center:
Head & neck cancer
Microvascular free flap reconstruction
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Celecoxib
Lidocaine
Ketamine
Gabapentin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Analgesics, Non-Narcotic
Antipyretics