Non-Narcotics vs Narcotics for Shoulder Surgery Postoperative Pain

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: The Cooper Health System

Must not be taking: Opioids

Disqualifiers: Age under 14, Age over 25, Nonoperative labrum tear, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients who are already on opioid medications before surgery.

What data supports the effectiveness of the treatment Non-Narcotic Pain Modulation for shoulder surgery postoperative pain?

Research shows that using a combination of non-narcotic methods, like regional anesthesia and medications such as acetaminophen (a common pain reliever) and nonsteroidal anti-inflammatory drugs (NSAIDs), can effectively control pain after shoulder surgery and reduce the need for narcotics. ^{1 2 3 4 5}

Is it safe to use non-narcotic pain treatments after shoulder surgery?

Research shows that using a combination of non-narcotic pain treatments can reduce the need for opioids (strong painkillers) and their side effects after shoulder surgery, suggesting these treatments are generally safe for managing pain. ^{2 3 4 6 7}

How does Non-Narcotic Pain Modulation treatment differ from other treatments for shoulder surgery pain?

Non-Narcotic Pain Modulation is unique because it focuses on using multiple non-drug methods to manage pain, reducing the need for narcotics (strong painkillers) and their side effects. This approach combines different techniques like regional anesthesia and local anesthetics to effectively control pain without relying on opioids. ^{2 3 5 8 9}

What is the purpose of this trial?

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.

Research Team

Catherine J Fedorka, MD

Principal Investigator

Cooper Hospital Orthopedic Surgery

Eligibility Criteria

This trial is for young individuals aged 15-25 who are undergoing surgery for a shoulder labrum tear. It's not open to those under 14, over 25, with nonoperative tears, opting out of surgery, or already on opioids before the operation.

Inclusion Criteria

I am between 15 and 25 years old.

I am diagnosed with a labrum tear and will have surgery.

Exclusion Criteria

I have been diagnosed with a labrum tear without surgery.

I have chosen not to have surgery for my condition.

I am taking opioid medications before surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo shoulder labrum repair and receive either narcotic or non-narcotic pain management postoperatively

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and medication use through a pain journal and pill count

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Non-Narcotic Pain Modulation

Trial Overview The study compares pain management strategies after shoulder labrum repair: one group receives Tylenol and Ibuprofen (non-narcotics), while another gets these plus Oxycodone (a narcotic). Participants will track their pain and medication use post-surgery.

Participant Groups

Group I: Experimental - Non-narcotic only Experimental Treatment 1 Intervention

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

Group II: Control - Narcotic Prescription Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

The Cooper Health System

Lead Sponsor

Trials

82

Recruited

35,600+

New Jersey Health Foundation

Collaborator

Trials

3

Recruited

220+

New Jersey Health Foundation

Collaborator

Findings from Research

Patients who received a multimodal analgesia regimen after shoulder arthroplasty reported lower pain scores and consumed significantly less opioids compared to those on a standard opioid-based regimen, indicating better pain management.

The multimodal approach also resulted in shorter hospital stays (1.44 days vs 1.91 days) without increasing the risk of complications or readmissions, demonstrating its safety and efficacy in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal analgesia decreases opioid consumption after shoulder arthroplasty: a prospective cohort study. McLaughlin, DC., Cheah, JW., Aleshi, P., et al.[2018]

Effective management of postoperative pain after shoulder surgery is crucial for improving patient outcomes and reducing reliance on narcotic medications.

The article reviews various multimodal analgesia strategies, highlighting their benefits and drawbacks, and suggests a pain management algorithm to optimize pain control during the perioperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative pain management for shoulder surgery: evolving techniques. Patel, MS., Abboud, JA., Sethi, PM.[2021]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Simple frameshifts in minimally invasive surgery postoperative pain management significantly reduce opiate prescriptions. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Narcotic requirements after shoulder arthroplasty are low using a multimodal approach to pain. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Multimodal analgesia decreases opioid consumption after shoulder arthroplasty: a prospective cohort study. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Multimodal Nonopioid Pain Protocol Provides Better or Equivalent Pain Control Compared to Opioid Analgesia Following Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Controlled Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Pain Management Strategies in Shoulder Arthroplasty. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Associated With Preoperative Opioid Use in Various Shoulder Surgical Procedures: A Systematic Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Elective Shoulder Surgery in the Opioid Naïve: Rates of and Risk Factors for Long-term Postoperative Opioid Use. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Continuous interscalene brachial plexus block versus parenteral analgesia for postoperative pain relief after major shoulder surgery. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Perioperative pain management for shoulder surgery: evolving techniques. [2021]