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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores pain management after shoulder surgery, focusing on labrum tear repairs. It compares two groups: one using only non-narcotic pain relievers like Tylenol and ibuprofen, and another using these plus the narcotic oxycodone. The goal is to determine if the non-narcotic approach (non-narcotic pain modulation) controls pain just as effectively. This trial targets individuals aged 15 to 25 undergoing surgery for a labrum tear who are not already taking opioid medications. Participants will track their pain and medication use in a journal for two weeks following surgery. As a Phase 4 trial, this study involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.

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 is the safety track record for these treatments?

Previous studies found that patients using a combination of non-opioid medications like Tylenol (acetaminophen) and ibuprofen experienced pain relief equal to or better than those using opioids after surgery. Research has shown that these non-narcotic treatments are generally well-tolerated and have few side effects. Many people use these common over-the-counter medications without problems.

In this trial, the experimental group will use non-narcotic medications like Tylenol and ibuprofen, which are generally safe when taken as directed. Some studies have raised concerns about ibuprofen and similar drugs affecting bone and tendon healing, but these findings mostly come from animal studies.

Overall, past research suggests the safety of the non-narcotic approach is promising. Participants will also have access to additional pain relief if needed, ensuring their comfort and safety during the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about non-narcotic pain modulation for shoulder surgery because it offers a way to manage pain without relying on narcotics like oxycodone, which can be addictive and have significant side effects. This approach uses a combination of Tylenol and Ibuprofen to control pain, potentially reducing the risk of dependency and enhancing patient safety. By providing effective pain relief without narcotics, this method could transform postoperative care, making it safer and more sustainable for patients.

What evidence suggests that this trial's treatments could be effective for postoperative pain in shoulder surgery?

Research has shown that non-narcotic pain relievers like ibuprofen and acetaminophen can effectively manage post-surgery pain. One review found that ibuprofen use after surgery reduces the need for stronger drugs like opioids and lowers pain levels. Another study found that 83.8% of patients using non-opioid pain relief experienced significant improvement. In this trial, one group will receive only non-narcotic pain management, while another group will receive a narcotic prescription including oxycodone. These findings support non-narcotic pain management as a strong alternative to narcotics for managing pain after shoulder surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Catherine J Fedorka, MD

Principal Investigator

Cooper Hospital Orthopedic Surgery

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7592505/

Efficacy of non-opioid analgesics to control postoperative pain Based on the results of multiple clinical trials, MIV has been found to provide relief of moderate to severe acute pain, alone or in combination with other ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X2400179X

Effect of post-operative NSAID use on rotator cuff repair ... When comparing improvement in PROs, the NSAID group reached MCID at one year in 83.8 % of patients and the no NSAID group reached MCID at one year in 73.9 % of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12136622/

EFFECTIVENESS OF ORAL MEDICATIONS IN THE ... This systematic review and meta-analysis showed that the postoperative use of ibuprofen reduces the need for opioids and decreases patient pain levels in the ...

4. surgicoll.scholasticahq.com surgicoll.scholasticahq.com/article/77644-evidence-based-orthopaedic-post-operative-opioid-prescribing-recommendations-following-shoulder-surgery

Evidence-Based Orthopaedic Post-Operative Opioid ... There is a lack of comprehensive data regarding the extent of postoperative pain medication usage after orthopaedic shoulder surgery.

5. scholarlycommons.henryford.com scholarlycommons.henryford.com/cgi/viewcontent.cgi?article=1401&context=orthopaedics_articles

Multimodal Nonopioid Pain Protocol Provides Better or ... Purpose: To evaluate the efficacy of a multimodal nonopioid analgesic protocol in controlling postoperative pain compared.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2957391225000361

Clinical practice guidelines for postoperative pain ... Preoperative exercise can improve patients'physical function before surgery, promote skeletal muscle fiber growth, and accelerate postoperative wound healing.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274621005176

The effects of nonsteroidal anti-inflammatory medications ... However, animal studies have demonstrated negative effects of NSAIDs on bone and tendon healing after commonly performed procedures such as rotator cuff repair.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05488847

Opioid-Free Pain Protocol After Shoulder Arthroplasty In these studies, patients who received a multimodal nonopioid regimen had equivalent or better postoperative pain control compared to a standard opioid ...