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

• ClinicalTrials.gov Identifier: NCT05974423
• Recruitment Status: Enrolling by invitation
• First Posted: August 3, 2023
• Last Update Posted: August 3, 2023
• Sponsor: The Cooper Health System
• Collaborator: New Jersey Health Foundation
• Information provided by (Responsible Party): The Cooper Health System

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:

  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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

Patients will be assigned to one of the following groups:

• 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 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

• 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: December 16, 2022
• Estimated Primary Completion Date: December 1, 2024
• Estimated Study Completion Date: December 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 Name: 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 Name: Non-narcotic only

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New Jersey

Cooper University Hospital

Camden, New Jersey, United States, 08103

Sponsors and Collaborators

The Cooper Health System

New Jersey Health Foundation

Investigators

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

More Information

Publications:

Familiari F, Huri G, Simonetta R, McFarland EG. SLAP lesions: current controversies. EFORT Open Rev. 2019 Jan 28;4(1):25-32. doi: 10.1302/2058-5241.4.180033. eCollection 2019 Jan.

Hester WA, O'Brien MJ, Heard WMR, Savoie FH. Current Concepts in the Evaluation and Management of Type II Superior Labral Lesions of the Shoulder. Open Orthop J. 2018 Jul 31;12:331-341. doi: 10.2174/1874325001812010331. eCollection 2018.

Jain A, Aniq H, Mistry A. SLAP Injury and the Superior Labrum. Semin Musculoskelet Radiol. 2022 Oct;26(5):577-584. doi: 10.1055/s-0042-1758840. Epub 2022 Dec 19.

Matsuki K, Sugaya H. Complications after arthroscopic labral repair for shoulder instability. Curr Rev Musculoskelet Med. 2015 Mar;8(1):53-58. doi: 10.1007/s12178-014-9248-5.

Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.

O'Neill A, Lirk P. Multimodal Analgesia. Anesthesiol Clin. 2022 Sep;40(3):455-468. doi: 10.1016/j.anclin.2022.04.002. Epub 2022 Aug 2.

Elmallah RK, Chughtai M, Khlopas A, Newman JM, Stearns KL, Roche M, Kelly MA, Harwin SF, Mont MA. Pain Control in Total Knee Arthroplasty. J Knee Surg. 2018 Jul;31(6):504-513. doi: 10.1055/s-0037-1604152. Epub 2017 Jul 18.

Dada O, Gonzalez Zacarias A, Ongaigui C, Echeverria-Villalobos M, Kushelev M, Bergese SD, Moran K. Does Rebound Pain after Peripheral Nerve Block for Orthopedic Surgery Impact Postoperative Analgesia and Opioid Consumption? A Narrative Review. Int J Environ Res Public Health. 2019 Sep 5;16(18):3257. doi: 10.3390/ijerph16183257.

Hamilton TW, Athanassoglou V, Trivella M, Strickland LH, Mellon S, Murray D, Pandit HG. Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. Cochrane Database Syst Rev. 2016 Aug 25;2016(8):CD011476. doi: 10.1002/14651858.CD011476.pub2.

Kaye AD, Novitch MB, Carlson SF, Fuller MC, White SW, Haroldson AR, Kaiser JA, Elkersh MA, Brunk AJ, Jeha GM, Cornett EM. The Role of Exparel Plus Meloxicam for Postoperative Pain Management. Curr Pain Headache Rep. 2020 Jan 30;24(3):6. doi: 10.1007/s11916-020-0837-2.

Blair HA. Bupivacaine/Meloxicam Prolonged Release: A Review in Postoperative Pain. Drugs. 2021 Jul;81(10):1203-1211. doi: 10.1007/s40265-021-01551-9. Epub 2021 Jul 6.

• Responsible Party: The Cooper Health System
• ClinicalTrials.gov Identifier: NCT05974423
• Other Study ID Numbers: IRB 22-193
• First Posted: August 3, 2023
• Last Update Posted: August 3, 2023
• Last Verified: July 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Cooper Health System:

Labrum repair; opioid consumption; postoperative pain

Additional relevant MeSH terms:

Pain, Postoperative; Acute Pain; Rotator Cuff Injuries; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Acetaminophen; Ibuprofen; Oxycodone; Narcotics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Central Nervous System Depressants; Antipyretics