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Non-Narcotics vs Narcotics for Shoulder Surgery Postoperative Pain

Phase 4

Waitlist Available

Led By Catherine J Fedorka, MD

Research Sponsored by The Cooper Health System

Eligibility Criteria Checklist

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

Must have

Patients between the ages of 15 - 25 years old

Patients with a diagnosis of a labrum tear who will undergo surgical intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

Study Summary

This trial aims to compare pain levels post-shoulder surgery when treated with non-narcotic meds vs. narcotic meds. Participants will be randomly assigned to either group, and complete a pain journal and pill count.

Who is the study for?

This trial is for young individuals aged 15-25 who are undergoing surgery for a shoulder labrum tear. It's not open to those under 14, over 25, with nonoperative tears, opting out of surgery, or already on opioids before the operation.Check my eligibility

What is being tested?

The study compares pain management strategies after shoulder labrum repair: one group receives Tylenol and Ibuprofen (non-narcotics), while another gets these plus Oxycodone (a narcotic). Participants will track their pain and medication use post-surgery.See study design

What are the potential side effects?

Possible side effects from Tylenol and Ibuprofen include stomach upset, bleeding risks, liver damage with high doses; Oxycodone can cause nausea, constipation, addiction risk and may affect breathing.

Eligibility Criteria

Inclusion Criteria

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

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I am between 15 and 25 years old.

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I am diagnosed with a labrum tear and will have surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Postoperative pain control

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental - Non-narcotic onlyExperimental Treatment1 Intervention

This group will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription of oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions: Tylenol 1000 mg every 8 hours Ibuprofen 600 mg every 6 hours as needed for pain

Group II: Control - Narcotic PrescriptionActive Control1 Intervention

Oxycodone 5 mg 1 tablet every 6 hours PRN Tylenol 1000 mg every 8 hours Ibuprofen 600 mg every 6 hours as needed for pain

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor

76 Previous Clinical Trials

33,053 Total Patients Enrolled

2 Trials studying Postoperative Pain

310 Patients Enrolled for Postoperative Pain

New Jersey Health FoundationUNKNOWN

2 Previous Clinical Trials

155 Total Patients Enrolled

Catherine J Fedorka, MDPrincipal InvestigatorCooper Hospital Orthopedic Surgery

3 Previous Clinical Trials

350 Total Patients Enrolled

2 Trials studying Postoperative Pain

310 Patients Enrolled for Postoperative Pain

Media Library

Non-Narcotic Pain Modulation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05974423 — Phase 4

Postoperative Pain Research Study Groups: Control - Narcotic Prescription, Experimental - Non-narcotic only

Postoperative Pain Clinical Trial 2023: Non-Narcotic Pain Modulation Highlights & Side Effects. Trial Name: NCT05974423 — Phase 4

Non-Narcotic Pain Modulation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05974423 — Phase 4

Frequently Asked Questions

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

Is eligibility for this research project open to individuals of an advanced age?

"This experiment has a set age limit of between 15 and 25 years old; anyone younger or older would not be eligible to take part."

Answered by AI

Is Experimental - Non-narcotic a reliable and secure option for individuals?

"The safety of Experimental - Non-narcotic only was rated a 3 on the 1 to 3 scale due to its Phase 4 status, signifying that it has been approved for use."

Answered by AI

Is it possible for me to enroll in this research initiative?

"To gain admittance into this medical trial, subjects must suffer from postoperative pain and be between the ages of 15-25. A total of 60 participants are sought for the study."

Answered by AI

Are there any available opportunities for participants in this research?

"According to information on clinicaltrials.gov, this research endeavor has concluded its recruitment of participants and is no longer taking applications. The trial was initially posted in December 2022 and most recently updated July 2023; nonetheless, there are currently 797 other trials actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation After Labrum Repair

2022. "Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation After Labrum Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05974423.

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