Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery
NCT ID: NCT04176419
Last Updated: 2024-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
30 participants
INTERVENTIONAL
2020-01-17
2021-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
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.
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
Acetaminophen
1,000 mg orally at time of check-in to the preoperative unit
Gabapentin
600 mg orally at time of check in to the preoperative unit
Celecoxib
200 mg orally at time of check in to the preoperative unit
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.
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.
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
Placebo Acetaminophen
1,000 mg orally at time of check-in to the preoperative unit
Placebo Gabapentin
600 mg orally at time of check in to the preoperative unit
Placebo Celecoxib
200 mg orally at time of check in to the preoperative unit
Interventions
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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.
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.
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
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
Acetaminophen
1,000 mg orally at time of check-in to the preoperative unit
Placebo Acetaminophen
1,000 mg orally at time of check-in to the preoperative unit
Gabapentin
600 mg orally at time of check in to the preoperative unit
Placebo Gabapentin
600 mg orally at time of check in to the preoperative unit
Celecoxib
200 mg orally at time of check in to the preoperative unit
Placebo Celecoxib
200 mg orally at time of check in to the preoperative unit
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jamie Ku, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Locations
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Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE6319
Identifier Type: -
Identifier Source: org_study_id
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