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

Sponsor

The Cooper Health System (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05974423

Collaborator

New Jersey Health Foundation (Other)

Enrollment

Location

Arms

35.5

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain, Acute Opioid Use Labral Tear, Glenoid	Drug: Tylenol, Ibuprofen, and Oxycodone Drug: Tylenol and Ibuprofen only	Phase 4

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:

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

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:

Tylenol 1000 mg every 8 hours
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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be assigned to one of the following groups: Group 1: 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 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 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 painPatients will be assigned to one of the following groups:Group 1:Oxycodone 5 mg 1 tablet every 6 hours PRN Tylenol 1000 mg every 8 hours Ibuprofen 600 mg every 6 hours as needed for painGroup 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 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 16, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control - Narcotic Prescription 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	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: Tylenol 1000 mg every 8 hours 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

Arm

Intervention/Treatment

Active Comparator: Control - Narcotic Prescription

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

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: Tylenol 1000 mg every 8 hours 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

Outcome Measures

Primary Outcome Measures

Postoperative pain control [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.