Methylprednisolone for Pain Management After ACL Surgery

Overseen By Allison Gruender

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: St. Louis University

Must not be taking: Glucocorticoids, Anticoagulants

Disqualifiers: Substance abuse, Chronic opioid use, 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: 4

Duration: 2 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding methylprednisolone, a type of steroid, to standard pain treatment can better manage pain after ACL surgery. The goal is to determine if it reduces pain and the need for opioids, which often have side effects and risks. Participants are divided into two groups: one receiving standard pain medications and the other receiving methylprednisolone in addition. Individuals undergoing ACL surgery without other major injuries or a history of substance abuse may be suitable for this study. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are taking oral or injectable glucocorticoids or have taken them within a month before the procedure. Also, if you have allergies or conditions that prevent you from using certain pain medications, you may not be eligible.

What is the safety track record for methylprednisolone?

Research has shown that methylprednisolone, a type of steroid, is usually well-tolerated by patients. One study found that taking this steroid in pill form helped 78% of patients regain normal movement after ACL surgery without major problems. Another study found that steroid injections after an ACL injury did not increase the risk of infection. These findings suggest that methylprednisolone is safe to use after ACL surgery, with a low chance of causing issues. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Methylprednisolone for pain management after ACL surgery because it offers a different approach compared to standard pain relief methods. Unlike typical pain treatments that primarily rely on opioids like Hydrocodone, Methylprednisolone is a corticosteroid that works by reducing inflammation, which is a significant cause of pain post-surgery. This anti-inflammatory action can potentially reduce the need for opioids, decreasing the risk of addiction and side effects associated with long-term opioid use. Additionally, Methylprednisolone may provide more rapid pain relief, helping patients recover faster and more comfortably.

What evidence suggests that methylprednisolone might be an effective treatment for pain management after ACL surgery?

Research has shown that methylprednisolone, a type of steroid, helps manage pain and swelling. It is particularly effective in aiding normal movement after knee issues. One study found that 78% of patients regained their movement after using steroids. In this trial, participants in the Medrol group will receive a Medrol dose pack, which includes methylprednisolone, along with Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as a pain regimen. This combination, including COX-2 inhibitors like Meloxicam, has provided better pain relief after ACL (anterior cruciate ligament) surgery. Evidence suggests that methylprednisolone may reduce pain and lessen the need for opioids after ACL surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Scott Kaar, MD

Principal Investigator

St. Louis University

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone ACL repair surgery and are experiencing pain. Participants should not have peripheral neuropathy, anosognosia, or any condition that would exclude them from safely receiving the study medications.

Inclusion Criteria

* Patient undergoing ACL repair or ACL reconstruction with tendon autograft

* Age 13-50 years old

* Able to provide informed consent or parent/legal guardian is able for minors

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a pain regimen including either Medrol or Ketorolac, along with other medications, after ACL repair surgery

2 weeks

Daily self-reporting via MyCap app

Follow-up

Participants are monitored for safety and effectiveness after treatment, with clinic visits at 2 weeks, 6 weeks, 12 weeks, and 1 year

1 year

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Methylprednisolone

Trial Overview The trial is testing whether adding a steroid called methylprednisolone to standard pain management after ACL surgery can reduce pain and opioid use without increasing complications. Patients will receive various medications including meloxicam, gabapentin, hydrocodone/acetaminophen, and ketorolac.

How Is the Trial Designed?

Group I: No Medrol group Active Control 3 Interventions

Patients will receive Ketorolac, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.

Group II: Medrol group Active Control 4 Interventions

Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery.

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials

197

Recruited

41,400+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18442688/

Oral Corticosteroid Use for Loss of Flexion After Primary ... The use of oral corticosteroids, in the form of an MDP, was associated with a successful return of normal range of motion in 78% of patients with early ...

2. medcentral.com medcentral.com/pain/chronic/pain-management-after-acl-surgery

Pain Management After ACL Surgery The patient will experience pain and swelling around the knee. There are a number of techniques that can be used to reduce the pain.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12142901/

Effectiveness and analgesic effect of local infiltration ... This study aims to explore the best analgesia method with the local infiltration analgesia (LIA) and femoral nerve block (FNB) after ACLR.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/j.1399-6576.2011.02584.x

Short stay and less pain after ambulatory anterior cruciate ... The combination of a COX-2 inhibitor and dexamethasone results in better pain relief 24 h after surgery in patients undergoing outpatient ACL ...

5. ecios.org ecios.org/DOIx.php?id=10.4055/cios23149

Meta-Analysis of Randomized Controlled Trials In summary, LAI offers a simpler method of achieving pain relief without the motor weakness associated with RNB. It also allows surgeons to ...

6. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/aspiration-and-corticosteroid-injection-are-safe-after-acl-injury

Aspiration and Corticosteroid Injection Are Safe After ACL Injury Corticosteroids injected after ACL injury but before ACL reconstruction do not raise the risk of infection.

7. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(07)01042-0/abstract

Oral Corticosteroid Use for Loss of Flexion After Primary ... The use of oral corticosteroids, in the form of an MDP, was associated with a successful return of normal range of motion in 78% of patients with early ...

8. researchgate.net researchgate.net/publication/5409074_Oral_Corticosteroid_Use_for_Loss_of_Flexion_After_Primary_Anterior_Cruciate_Ligament_Reconstruction

Oral Corticosteroid Use for Loss of Flexion After Primary ... Of the 23 patients treated with an MDP, 5 (22%) were considered failures because they required surgical intervention for persistent loss of ...

9. journals.lww.com journals.lww.com/md-journal/fulltext/2021/11120/the_efficacy_of_5_rehabilitation_treatments_after.45.aspx

The efficacy of 5 rehabilitation treatments after anterior... The efficacy of traditional rehabilitation, proprioceptive training, and neuromuscular training after anterior cruciate ligament (ACL) ...