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Non-Opioid Pain Management for Postoperative Pain in Head and Neck Cancer
Phase 3
Waitlist Available
Led By Jamie Ku, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing head & neck free flap reconstruction at the Cleveland Clinic Main Campus
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-op, 24 hours postop, and 48 hours postop
Awards & highlights
Study Summary
This trial will test a new way to control pain during and after surgery for head and neck cancer that doesn't use opioids.
Who is the study for?
This trial is for adults with head and neck cancer who are undergoing free flap reconstruction surgery at the Cleveland Clinic Main Campus. They must understand and sign consent, have normal kidney and liver function, no recent drug abuse or significant illness that could affect study participation, and no allergies to pain medications being tested.Check my eligibility
What is being tested?
The study tests a non-opioid pain control regimen before and during surgery to see if it reduces postoperative pain and opioid use after head & neck cancer surgery. Patients will receive either placebo or actual drugs like Ketamine, Lidocaine, Acetaminophen, Gabapentin, or Celecoxib.See study design
What are the potential side effects?
Possible side effects of the drugs include allergic reactions for those sensitive to ingredients in Ketamine, Lidocaine, Acetaminophen, Gabapentin or Celecoxib; organ-specific issues such as heart problems from Lidocaine; plus general medication-related risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having head & neck surgery with tissue reconstruction at Cleveland Clinic.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-op, 24 hours postop, and 48 hours postop
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-op, 24 hours postop, and 48 hours postop
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain levels on Visual Analog Scale (VAS)
Total opioid consumption measured in daily morphine equivalent
Secondary outcome measures
Average Opioid Related Symptom Distress Scale (ORSDS) scores
Average Patient satisfaction with pain management scores
Time to first flatulence and defecation
Side effects data
From 2010 Phase 2 trial • 255 Patients • NCT010621135%
Beta 2 microglobulin increased
3%
Beta-N-acetyl-D-glucosaminidase increased
3%
Blood bilirubin increased
2%
Eczema
1%
White blood cell count increased
1%
Blood urine present
1%
Hypoaesthesia facial
1%
Rash
1%
Post procedural haemorrhage
1%
Blood creatine phosphokinase increased
1%
Blood phosphorus decreased
1%
Urobilin urine present
1%
Presyncope
1%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Initial Dose Celecoxib 400 mg
Additional Dose Placebo
Additional Dose Celecoxib 200 mg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment5 Interventions
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.
Group II: Control GroupPlacebo Group5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
2011
Completed Phase 4
~1360
Ketamine
2011
Completed Phase 4
~1090
Celecoxib
2019
Completed Phase 4
~1740
Acetaminophen
2017
Completed Phase 4
~2030
Gabapentin
2013
Completed Phase 4
~1550
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,880 Total Patients Enrolled
Jamie Ku, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver tests are not within the normal range.You have had allergic reactions to drugs similar to Ketamine or Lidocaine.I am having head & neck surgery with tissue reconstruction at Cleveland Clinic.My kidney function is poor (creatinine ≥ 2 mg/dl).I cannot use lidocaine due to heart issues.You have used illegal drugs, except for tobacco and alcohol, in the last 6 months.You have had an allergic reaction to lidocaine, ketamine, acetaminophen, gabapentin, or celecoxib in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Treatment Group
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Celecoxib a common medication used in clinical trials?
"As of now, there are a total of 401 active clinical trials for Celecoxib. Out of those, 91 have reached Phase 3 testing. The majority of these studies take place in Scottsdale, Arizona; however, there are 3696 locations running trials for this treatment globally."
Answered by AI
Has the FDA looked into Celecoxib as a viable drug?
"Celecoxib is rated as a 3 in terms of safety. This designation comes from it being a Phase 3 trial, which means that while there is still some testing to be done in regards to efficacy, there is plenty of data supporting its safety."
Answered by AI
How many individuals are being helped by this lenalidomide study?
"That is correct. According to the latest update on clinicaltrials.gov, this study is still looking for qualified participants. The trial was first posted on January 17th 2020 and has since been updated on May 11th 2022. They are looking for a total of 292 individuals at 1 site."
Answered by AI
For what sorts of medical conditions is Celecoxib prescribed?
"Celecoxib is most commonly used as an intervention for minor burns. It can also be prescribed to treat multiple other conditions, such as catarrh, transplantation, and end-stage chronic kidney failure."
Answered by AI
Are participants being enrolled in this research project at this time?
"Yes, this is an active recruitment trial that was originally posted on 1/17/2020. The most recent update was on 5/11/2022. Currently, the study is looking for 292 more participants at 1 location."
Answered by AI
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