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

July 26, 2023 updated by: The Cooper Health System

Prospective Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation Following a Labrum Repair

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The opioid crisis has illuminated the risks of opioid use for pain management, with renewed interest in reducing opioid consumption after common orthopedic procedures. Anti-inflammatory medication is an important component of multimodal pain management for patients undergoing orthopedic surgery. Several relevant studies have inquired about the use of opioid consumption in the management of total knee arthroplasty, total hip arthroplasty, total shoulder arthroplasty as well as arthroscopic shoulder surgeries. There is currently a gap in the literature, however, regarding the use of nerve blocks preoperatively in conjunction with nonopioid pharmacology postoperatively for pain. The goal is to determine if this can reduce pain levels in patients who have undergone surgical management for shoulder labrum or SLAP lesions. Hopefully, the data we can extract will allow future physicians to decrease the number of opioids prescribed and reduce the risks of prolonging the opioid epidemic.

The United States is currently in an opioid crisis. This is a public health issue that not only is limited to the United States but is echoed by countries around the world. All physicians must be accountable for the continuation of the crisis but also must be cognizant of ways to end the issue. In 2011, the United States Food and Drug Administration reported that 50 million Americans were prescribed opioids which is close to a 100 percent increase in the amount prescribed in 2008. Similarly, during that same period, opioid overdose became the leading cause of accidental death in young adults; associated with a higher risk of postoperative death, and increased risk of falls and fractures in the elderly. Many ways have been discussed to reduce the prescription of opioids such as standardized opioid prescription protocols, limits on prescription size, and restrictions on opioid use for preoperative and nonsurgical patients. Another theater of opioid use that can be addressed is that of post-operative pain management. The contribution of the potential results of our research could greatly reduce and mitigate the number of opioids prescribed postoperatively if there is no significant difference between the groups.

This will be a prospective randomized trial. Patients will be randomly placed into either the control or experimental arm of the study. Every patient will receive Exparel as is the standard of care for this procedure.

There will be two groups in this study:

  • Group 1:

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

  • Group 2 (Experimental 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 for 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:

    1. Tylenol 1000 mg every 8 hours
    2. Ibuprofen 600 mg every 6 hours as needed for pain

At the time of diagnosis and discussion of surgical intervention, patients will be asked if they would like to participate in this research study. Patients will be considered screen fails should they meet any exclusion criteria. They will be informed that depending on which group they are randomly assigned to, they may have different prescriptions. Should the patient be randomly assigned to the control group, they will be given the above medications. Should the patient be randomly assigned to the experimental group, they will be given the above medication scripts.

To note, for shoulder surgeries, Cooper has been using Exparel as a nerve block agent as part of the standard of care.

Day 1 after surgery: both groups will begin completing their pain journal for 14 days. We will allow two methods to complete the pain journal: REDCap or paper format. The REDCap version will be emailed to patients daily so they can complete the questions. The paper format will be available to all subjects regardless of if they complete the REDCap surveys. This will be an extra measure to ensure all days are reported and there are no issues with the REDCap.

At 2 Weeks post-op: Patients' pain levels with be assessed in the immediate post-operative period at their first follow-up visit with their respective attending physician.

The subjects will keep track of pain levels through a pain journal which they fill out daily and will bring to the first post-operative appointment. At their first post-operative visit, patients will also bring their pill bottles for a pill count in the office to validate the amount described in the pain journal.

Both groups' subject's involvement will last 2 weeks post-operation. After this 2 week visit, patients will have completed their course of the study.

The current standard of practice at Cooper for orthopedic surgeons performing this procedure is oxycodone 5mg PRN, ibuprofen 600mg every 6 hours, and acetaminophen 1000mg every 8 hours.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients between the ages of 15 - 25 years old
  • Patients with a diagnosis of a labrum tear who will undergo surgical intervention

Exclusion Criteria:

  • Patients under the age of 14 years old
  • Patients age 26 years or older
  • Patients with a nonoperative diagnosis of a labrum tear
  • Patients who elect not to undergo surgical treatment
  • Patients who are on opioid medications preoperatively

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control - Narcotic Prescription
  1. Oxycodone 5 mg 1 tablet every 6 hours PRN
  2. Tylenol 1000 mg every 8 hours
  3. Ibuprofen 600 mg every 6 hours as needed for pain
Drug: Tylenol, Ibuprofen, and Oxycodone
A script for these three medications will be provided
Other Names:
  • Both Narcotic and Non-narcotic
Experimental: Experimental - Non-narcotic only

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:

  1. Tylenol 1000 mg every 8 hours
  2. Ibuprofen 600 mg every 6 hours as needed for pain
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
Other Names:
  • Non-narcotic only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain control
Time Frame: 2 weeks
The subjects will keep track of pain levels through a pain journal which they fill out daily and will bring to the first post-operative appointment. At their first post-operative visit, patients will also bring their pill bottles for a pill count in the office to validate the amount described in the pain journal.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cooper Health System

Collaborators

New Jersey Health Foundation

Investigators

  • Principal Investigator: Catherine J Fedorka, MD, Cooper Hospital Orthopedic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 22-193

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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