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Opioid Reduced Regimen for Postoperative Pain

N/A

Recruiting

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

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

Must have

Adult patients age 18-80 years

Primary hip arthroscopy

Must not have

Opioid tolerant patients

Revision surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months postoperatively

Summary

This trial will study whether giving patients fewer opioid pills following surgery reduces the risk of addiction.

Who is the study for?

This trial is for adults aged 18-80 who speak English, have not taken opioids in the last 6 weeks, and are undergoing their first hip arthroscopy. They must consent to participate and be opioid-naive. People with severe joint damage, prior infections, substance use disorders, certain chronic diseases or pain conditions, previous surgery on the same joint, or a recent history of cancer cannot join.

What is being tested?

The study compares two post-surgery pain management plans after primary hip arthroscopy: one group receives a reduced number of opioid pills plus gabapentin and Tylenol; the other gets a standard regimen with more opioids. Patients will be randomly assigned to either group after giving consent.

What are the potential side effects?

Possible side effects include those related to Norco (opioid) such as nausea, vomiting, constipation, drowsiness or addiction risk. Gabapentin may cause dizziness or fatigue while Tylenol could potentially lead to liver issues if used excessively.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 80 years old.

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I am having my first hip arthroscopy.

Exclusion Criteria

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

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I regularly use opioids without severe side effects.

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I am scheduled for or have had a revision surgery.

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I have had infections in the joint where I had surgery.

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I have a long-term pain condition like low back pain or fibromyalgia.

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I am under 18 years old.

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I have severe cartilage damage.

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I have not had any cancer in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months postoperatively for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of unused opioid pills

Opioid disposal rates

Pain Score

+1 more

Secondary study objectives

Harris Hip score

Hip structure

Hip outcome score

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental Group - Opioid ReducedExperimental Treatment1 Intervention

Experimental - opioid reduced: 50% less oxycodone relative to control group * Tylenol extra strength (1000 mg, three times daily for 10 days following surgery) * Gabapentin (300 mg at night for 10 days following surgery) * Norco (hydrocodone-acetaminophen) 5mg-325mg, 5 total pills The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days).

Group II: Control GroupPlacebo Group1 Intervention

Control Group will receive the following pain medication regimen: - Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days).

0 / 9Eligibility criteria met