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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 14 days post-operatively

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in pain score

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

Acetaminophen

2017

Completed Phase 4

~2030

Methocarbamol

2016

Completed Phase 4

~480

Ibuprofen

2013

Completed Phase 4

~5800

Gabapentin

2013

Completed Phase 4

~1550

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,209 Previous Clinical Trials

3,766,946 Total Patients Enrolled

1 Trials studying Hip Arthroscopy

250 Patients Enrolled for Hip Arthroscopy

Kelechi Okoroha, MDPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

68 Total Patients Enrolled

Media Library

Nonopioid Pain Control Regimen (Non-opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05076110 — Phase 4

Hip Arthroscopy Research Study Groups: Standard of Care Group, Non-Opiate Pain Control Group

Hip Arthroscopy Clinical Trial 2023: Nonopioid Pain Control Regimen Highlights & Side Effects. Trial Name: NCT05076110 — Phase 4

Nonopioid Pain Control Regimen (Non-opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05076110 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation accommodate the elderly population over 85 years of age?

"Participants between the ages of 16 and 60 are eligible for this medical research study. For those younger than 16, there are 42 additional trials available while 92 are open to patients 65 or older."

Answered by AI

What other research studies have explored the applications of Acetaminophen?

"Presently, there are 141 Acetaminophen trials in operation with 41 of them in the late-stage Phase 3. Although most investigations are centred around Pittsburgh, Pennsylvania, the treatment has been trialled at 1106 separate sites worldwide."

Answered by AI

How hazardous is Acetaminophen to individuals' health?

"The safety of acetaminophen has been assessed at a 3 on our scale, as this is a Phase 4 trial and the medication has already obtained regulatory approval."

Answered by AI

What is the current total of participants being treated as part of this research?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical experiment was first made available April 7th 2022 and has been recently updated May 3rd 2022. Currently 188 participants are being recruited from three different sites."

Answered by AI

What ailments is Acetaminophen usually prescribed to alleviate?

"Acetaminophen is regularly prescribed to alleviate pain but also helps manage symptoms of rest, catarrh, and rhinorrhoea."

Answered by AI

Is recruitment open for this trial?

"Data hosted on clinicaltrials.gov demonstrates that this research initiative, which was initially posted April 7th 2022, is still actively recruiting participants. The entry was most recently revised May 3rd 2022."

Answered by AI

What is the eligibility criteria for individuals to take part in this research?

"Admission to this trial necessitates a prior arthroscopy and being between the ages of sixteen and sixty. To meet their desired patient pool, 188 applicants are needed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

Kelechi R. Okoroha 2022. "Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05076110.

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