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

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ClinicalTrials.gov Identifier: NCT04176419
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE November 21, 2019
First Posted Date  ICMJE November 25, 2019
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE January 17, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2019)
  • Total opioid consumption measured in daily morphine equivalent [ Time Frame: at 48 hours postop ]
    Total opioid consumption measured in daily morphine equivalent
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2019)
  • 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).
  • 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.
  • Time to first flatulence and defecation [ Time Frame: an average of 7 days ]
    Time to first flatulence and defecation from end of surgical case
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Postoperative Pain Control
  • Opioid Consumption
Intervention  ICMJE
  • 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: 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: 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: 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: Acetaminophen
    1,000 mg orally at time of check-in to the preoperative unit
    Other Names:
    • Paracetamol
    • Tylenol
    • N-acetyl-para-aminophenol
    • APAP
  • Drug: Placebo Acetaminophen
    1,000 mg orally at time of check-in to the preoperative unit
  • Drug: Gabapentin
    600 mg orally at time of check in to the preoperative unit
    Other Name: Neurontin
  • Drug: Placebo Gabapentin
    600 mg orally at time of check in to the preoperative unit
  • Drug: Celecoxib
    200 mg orally at time of check in to the preoperative unit
    Other Name: Celebrex
  • Drug: Placebo Celecoxib
    200 mg orally at time of check in to the preoperative unit
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Ketamine
    • Drug: Lidocaine
    • Drug: Acetaminophen
    • Drug: Gabapentin
    • Drug: Celecoxib
  • 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.

    Interventions:
    • Drug: Placebo Ketamine
    • Drug: Placebo Lidocaine
    • Drug: Placebo Acetaminophen
    • Drug: Placebo Gabapentin
    • Drug: Placebo Celecoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 22, 2019)
292
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jamie Ku, MD 1-866-223-8100 TaussigResearch@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04176419
Other Study ID Numbers  ICMJE CASE6319
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jamie Ku, MD Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP