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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months postoperatively

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Number of unused opioid pills

Opioid disposal rates

Pain Score

+1 more

Secondary outcome measures

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 / 2Eligibility criteria met

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Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,331 Total Patients Enrolled

Media Library

Opioid reduced regimen Clinical Trial Eligibility Overview. Trial Name: NCT04094701 — N/A

Opioid Use Disorder Research Study Groups: Experimental Group - Opioid Reduced, Control Group

Opioid Use Disorder Clinical Trial 2023: Opioid reduced regimen Highlights & Side Effects. Trial Name: NCT04094701 — N/A

Opioid reduced regimen 2023 Treatment Timeline for Medical Study. Trial Name: NCT04094701 — N/A

Frequently Asked Questions

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

Are there any opportunities for individuals to participate in this trial at the present time?

"According to the records hosted on clinicaltrials.gov, enrollment for this medical trial is open. It was initially unveiled on October 21st 2020 and its most recent update occurred on July 28th 2023."

Answered by AI

How many individuals are being recruited for this research investigation?

"Affirmative. Clinicaltrials.gov confirms that this research endeavour, which was published on October 21st 2020, is presently recruiting participants. Approximately 170 patients need to be enlisted at a single medical facility."

Answered by AI

Does this research project accept participants who are of legal age?

"This trial is only open to participants aged between 18 and 80, with 97 trials for minors under the age of consent and 448 studies available for those over 65."

Answered by AI

Am I eligible to participate in this research?

"This clinical trial is accepting 170 individuals aged 18-80 that are opioid naive (no intake of opioids within the last 6 weeks) and have a confirmed diagnosis of OUD. Furthermore, they must be capable of comprehending English and providing written consent to participate in the study. These patients will then undergo primary hip arthroscopy surgery as part of their enrollment."

Answered by AI

What is the desired outcome of this experiment?

"This clinical trial seeks to measure opioid disposal rates in the first month following discharge. Secondary objectives include a Harris Hip Score, with higher scores representing less dysfunction; an International Hip Outcome Tool which quantifies patient responses on a Visual Analog Scale (VAS); and finally, a Hip Outcome Score composed of two subscales: Activities of Daily Living (ADL) and Sports. The maximum achievable score for this metric is 68 points."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hip Arthroscopy Postoperative Opioid Demands

2020. "Hip Arthroscopy Postoperative Opioid Demands". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04094701.

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