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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

Must not have

Inadequate hepatic function (total bilirubin ≥ 2 x the institutional ULN and/or AST or ALT ≥3 x the institutional ULN) within 30 days

Inadequate renal function (serum creatinine ≥ 2 mg/dl) within 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-op, 24 hours postop, and 48 hours postop

Awards & highlights

Pivotal Trial

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver tests are not within the normal range.

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My kidney function is poor (creatinine ≥ 2 mg/dl).

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I cannot use lidocaine due to heart issues.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain levels on Visual Analog Scale (VAS)

Total opioid consumption measured in daily morphine equivalent

Secondary study objectives

Average Opioid Related Symptom Distress Scale (ORSDS) scores

Average Patient satisfaction with pain management scores

Time to first flatulence and defecation

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Ketamine

2011

Completed Phase 4

~1120

Gabapentin

2013

Completed Phase 4

~1550