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Non-opioid Analgesic

Nonopioid Pain Medication for Post-Surgical Hip Pain

Phase 4

Recruiting

Led By Kelechi Okoroha, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN)

Be younger than 65 years old

Must not have

Medical history of known allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin

Peptic ulcer disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 14 days post-operatively

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing whether a new pain medication can help control pain after surgery without using narcotic drugs.

Who is the study for?

This trial is for individuals scheduled for a primary hip arthroscopy at Mayo Clinic, Rochester, MN. It's not suitable for those with allergies to pain medications like Motrin or Tylenol, history of substance abuse, recent narcotic use, pregnant women, or people with kidney issues or stomach ulcers.

What is being tested?

The study tests the effectiveness of a non-narcotic pain control regimen after hip surgery using Acetaminophen (Tylenol), Methocarbamol (Robaxin), Oxycodone (a mild opioid), Ibuprofen (Motrin), and Gabapentin.

What are the potential side effects?

Possible side effects include digestive discomfort from Ibuprofen and Acetaminophen; drowsiness or dizziness from Methocarbamol and Gabapentin; and constipation or nausea from Oxycodone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a hip arthroscopy at Mayo Clinic in Rochester, MN.

Exclusion Criteria

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

Select...

I am allergic or intolerant to common pain or inflammation medications.

Select...

I have been diagnosed with peptic ulcer disease.

Select...

I have had bleeding in my digestive tract.

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I have kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 14 days post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 14 days post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 14 days post-operatively for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in pain score

Awards & Highlights

Pivotal Trial

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-Opiate Pain Control GroupExperimental Treatment4 Interventions

Subjects will receive a non-opiate pain control regime using Ibuprofen, Gabapentin, Acetaminophen, Methocarbamol for pain control following hip arthroscopy procedure.

Group II: Standard of Care GroupActive Control1 Intervention

Subjects will receive standard of care pain medication Oxycodone for pain control following hip arthroscopy procedure

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methocarbamol

2016

Completed Phase 4

~480

Gabapentin

2013