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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 below
Select...
I am having head & neck surgery with tissue reconstruction at Cleveland Clinic.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-op, 24 hours postop, and 48 hours postop
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-op, 24 hours postop, and 48 hours postop for reporting.

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 • NCT01062113
5%
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
~1370
Ketamine
2011
Completed Phase 4
~1120
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
455 Previous Clinical Trials
31,799 Total Patients Enrolled
Jamie Ku, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Media Library

Perioperative Analgesia (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04176419 — Phase 3
Post Operative Pain Management Research Study Groups: Control Group, Treatment Group
Post Operative Pain Management Clinical Trial 2023: Perioperative Analgesia Highlights & Side Effects. Trial Name: NCT04176419 — Phase 3
Perioperative Analgesia (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04176419 — Phase 3
~6 spots leftby Jun 2025
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