← Back to Search

Other

Standard of Care B for Head and Neck Cancers

Phase 4
Waitlist Available
Led By Lisa Shnayder, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the study period of approximately 1 year
Awards & highlights

Study Summary

This trial will compare two different pain management approaches for people undergoing head and neck surgery. One group will receive Tylenol and opioids as needed, while the other group will receive Gabapentin, Ketorolac, and Tylenol, with the Anesthesiology team managing regional nerve blocks. The team will observe pain scores and the amount of pain medication used to see if the use of Gabapentin, Ketorolac, and Tylenol reduces the use of opioids.

Eligible Conditions
  • Head and Neck Cancers
  • Pain relief

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the study period of approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the study period of approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean morphine equivalents for Arm A
Mean morphine equivalents for Arm B
Secondary outcome measures
Length of stay
Pain assessment for patients
Post-operative complications

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care BExperimental Treatment6 Interventions
Arm B, will include: Arm A description with addition.. Scheduled Ketorolac starting post-op day #1, 15 mg q6h (max 120 mg/day), for a total of 5 days Scheduled Gabapentin starting 7 days preoperatively to continue postoperatively Regional block per anesthesia protocol - Initial block: 0.5% bupivacaine, 20 ml Continuous infusion: 0.125% bupivacaine at 6 ml/hr with a 5 ml bolus available every 30 mins
Group II: Standard of Care AActive Control3 Interventions
Randomized controlled prospective trial to compare two standards of care for head and neck surgery pain management. Arm A, will include: Scheduled Tylenol 1000 mg IV one time dose intra-operatively, then 650 mg via PEG tube or PO Q4H to a max dose of 4gm/24 hrs Opioids prn based on Numeric Pain Scale (0-10, with 0 indicating no pain and 10 indicating worst pain ever): 0-3: no prn meds, reassurance, listen to music, watch TV. 4-7: Oxycodone 5 mg q4h prn via PEG tube or PO with a maximum of 30 mg/24 hours. 8-10 Morphine 2 mg IV q2h prn breakthrough pain.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
FDA approved
Oxycodone
FDA approved
Morphine
FDA approved
Gabapentin
FDA approved
Ketorolac
FDA approved
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
462 Previous Clinical Trials
169,177 Total Patients Enrolled
Lisa Shnayder, MDPrincipal InvestigatorKUMC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Multimodal Pain Study in Free Flap Patients
2019. "Multimodal Pain Study in Free Flap Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04246697.
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top