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

NCT05974423 | Unknown Phase 4 FDA Drug

• 1 other identifier: IRB 22-193
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Labrum repair; opioid consumption; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain control

  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

Study Arms (2)

Control - Narcotic Prescription

ACTIVE COMPARATOR

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

Experimental - Non-narcotic only

EXPERIMENTAL

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

Interventions

Tylenol, Ibuprofen, and Oxycodone DRUG

A script for these three medications will be provided

Also known as: Both Narcotic and Non-narcotic

Control - Narcotic Prescription

Tylenol and Ibuprofen only DRUG

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

Also known as: Non-narcotic only

Experimental - Non-narcotic only

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead
• New Jersey Health Foundation: collaborator

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Related Publications (11)

• 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.

  PMID: 30800477 BACKGROUND

• 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.

  PMID: 30197715 BACKGROUND

• 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.

  PMID: 36535593 BACKGROUND

• 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.

  PMID: 25532917 BACKGROUND

• 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.

  PMID: 34196965 BACKGROUND

• 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.

  PMID: 36049874 BACKGROUND

• 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.

  PMID: 28719941 BACKGROUND

• 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.

  PMID: 31491863 BACKGROUND

• 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.

  PMID: 27558150 BACKGROUND

• 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.

  PMID: 32002676 BACKGROUND

• 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.

  PMID: 34228280 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Rotator Cuff Injuries

Interventions

Acetaminophen; Ibuprofen; Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Catherine J Fedorka, MD

  Cooper Hospital Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: December 16, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: August 3, 2023

Record last verified: 2023-07

Locations

US (1)