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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 belowSelect...
I am between 15 and 25 years old.
Select...
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
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
Find a Location
Who is running the clinical trial?
The Cooper Health SystemLead Sponsor
78 Previous Clinical Trials
35,103 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 15 and 25 years old.I have been diagnosed with a labrum tear without surgery.I am diagnosed with a labrum tear and will have surgery.I have chosen not to have surgery for my condition.I am taking opioid medications before surgery.I am younger than 14 years old.I am 26 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Control - Narcotic Prescription
- Group 2: Experimental - Non-narcotic only
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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