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

NCT05974423 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-03

No results posted yet for this study

Summary

The purpose of this study is to determine if patients age 15 to 30 years old being treated for shoulder labrum repair and SLAP lesions have significant differences in pain levels postoperatively when treated with a combination therapy of ibuprofen, and acetaminophen compared to oxycodone. Participants will be randomly placed into either the control arm and receive scripts for non-narcotic medications (Tylenol and Ibuprofen) and opioids, or the experimental arm of the study. receiving only a prescription for the non-narcotic medications. Every patient will receive a preoperative Exparel nerve block as is the standard of care for this procedure. Both groups will fill out a pain journal for 14 days following surgery and complete a pill count at the first postoperative visit to validate the amount of pain medication documented in the pain journal.

Conditions

  • Postoperative Pain, Acute
  • Opioid Use
  • Labral Tear, Glenoid

Interventions

DRUG

Tylenol, Ibuprofen, and Oxycodone

A script for these three medications will be provided

DRUG

Tylenol and Ibuprofen only

A script for only these two medications will be provided initially following surgery. Should the patient need stronger medication for adequate pain control, the on-call physician will provide a script for oxycodone

Sponsors & Collaborators

  • New Jersey Health Foundation

    collaborator OTHER

  • The Cooper Health System

    lead OTHER

Principal Investigators

  • Catherine J Fedorka, MD · Cooper Hospital Orthopedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-16
Primary Completion
2024-12-01
Completion
2025-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05974423 on ClinicalTrials.gov