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

Primary Purpose

Postoperative Pain Control, Opioid Consumption

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Placebo Ketamine
Lidocaine
Placebo Lidocaine
Acetaminophen
Placebo Acetaminophen
Gabapentin
Placebo Gabapentin
Celecoxib
Placebo Celecoxib
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain Control focused on measuring Head & neck cancer, Microvascular free flap reconstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Control Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Total opioid consumption measured in daily morphine equivalent
Total opioid consumption measured in daily morphine equivalent
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)

Secondary Outcome Measures

Average Opioid Related Symptom Distress Scale (ORSDS) scores
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
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 to first flatulence and defecation from end of surgical case

Full Information

First Posted
November 21, 2019
Last Updated
October 4, 2023
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04176419
Brief Title
Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Control, Opioid Consumption
Keywords
Head & neck cancer, Microvascular free flap reconstruction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketamine Hydrochloride, Ketamine Hydrochloride Injection, USP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Lidocaine Hydrochloride and 5% dextrose, lidocaine hydrochloride injection
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo Lidocaine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Paracetamol, Tylenol, N-acetyl-para-aminophenol, APAP
Intervention Description
1,000 mg orally at time of check-in to the preoperative unit
Intervention Type
Drug
Intervention Name(s)
Placebo Acetaminophen
Intervention Description
1,000 mg orally at time of check-in to the preoperative unit
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
600 mg orally at time of check in to the preoperative unit
Intervention Type
Drug
Intervention Name(s)
Placebo Gabapentin
Intervention Description
600 mg orally at time of check in to the preoperative unit
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
200 mg orally at time of check in to the preoperative unit
Intervention Type
Drug
Intervention Name(s)
Placebo Celecoxib
Intervention Description
200 mg orally at time of check in to the preoperative unit
Primary Outcome Measure Information:
Title
Total opioid consumption measured in daily morphine equivalent
Description
Total opioid consumption measured in daily morphine equivalent
Time Frame
at 48 hours postop
Title
Pain levels on Visual Analog Scale (VAS)
Description
Change in pain levels on Visual Analog Scale (VAS 0-100mm scale with higher scores corresponding to more pain)
Time Frame
Pre-Op, 24 hours postop, and 48 hours postop
Secondary Outcome Measure Information:
Title
Average Opioid Related Symptom Distress Scale (ORSDS) scores
Description
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).
Time Frame
at 96 hours after surgery, and at discharge (an average of 1 week)
Title
Average Patient satisfaction with pain management scores
Description
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 Frame
at the time of discharge (an average of 1 week)
Title
Time to first flatulence and defecation
Description
Time to first flatulence and defecation from end of surgical case
Time Frame
an average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Ku, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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