Methylprednisolone for Postoperative Pain

AM
CT
Overseen ByCrystal Taylor
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the medication methylprednisolone, a corticosteroid, can reduce pain after ACL surgery. Participants will receive either this medication with their usual pain treatment or just the usual treatment. Researchers will compare the amount of pain medication each group requires and their reported pain levels over time. The trial seeks participants aged 14 to 65 who are scheduled for ACL reconstruction and have no issues with steroid medications. As a Phase 4 trial, this research involves an FDA-approved treatment and focuses on understanding its benefits for more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for methylprednisolone?

Research has shown that methylprednisolone is usually well-tolerated for managing pain after surgery. In a previous study, patients who took methylprednisolone after knee surgery reported less pain and required fewer painkillers, reducing side effects from those medications. While most studies highlight its benefits, some research found that methylprednisolone did not significantly relieve pain in other surgeries, such as heart surgeries.

This treatment is in a Phase 4 trial, indicating it is already approved for use and considered safe for certain conditions. Discussing possible side effects with a doctor is advisable, but current evidence suggests that methylprednisolone is safe for managing pain after surgeries like ACL repair.12345

Why are researchers enthusiastic about this study treatment?

Methylprednisolone is unique because it offers an anti-inflammatory approach to managing postoperative pain, which is different from the typical reliance on opioids and NSAIDs. Most treatments for post-surgery pain focus on blocking pain signals or reducing pain perception, but methylprednisolone targets inflammation, a root cause of pain. Researchers are excited about this treatment because it may reduce the need for opioids, potentially lowering the risk of dependency and side effects while offering effective pain control.

What is the effectiveness track record for methylprednisolone in treating postoperative pain for ACL reconstruction?

Research has shown that methylprednisolone effectively reduces pain after surgery. In studies involving knee surgery patients, this medication significantly lowered pain levels and reduced the need for strong painkillers. It also lessened opioid-related side effects, which is a significant advantage. In this trial, participants in the treatment group will receive a 4 mg oral 6-day methylprednisolone taper alongside standard post-operative pain control. The evidence strongly supports including methylprednisolone in the pain management plan to aid recovery after surgeries like ACL reconstruction. Solid data supports its use for managing pain after such surgeries.12467

Who Is on the Research Team?

AM

Amit Momaya, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for people aged 14 to 65 who are having ACL reconstruction surgery and do not have conditions that make steroid use unsafe. Participants must be able to give consent and follow the study procedures.

Inclusion Criteria

I am having ACL reconstruction surgery.
I am between 14 and 65 years old.

Exclusion Criteria

Contraindications to corticosteroids

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive a 4 mg oral 6-day methylprednisolone taper in addition to standard post-operative pain control

1 week
Daily monitoring (self-reported)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including range of motion and patient-reported outcomes

3 months
Visits at baseline, 2 weeks, 6 weeks, and 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Methylprednisolone

Trial Overview

The study compares adding a short course of oral methylprednisolone (a steroid) to standard pain control after ACL surgery versus using only the usual pain medications. Patients are randomly assigned to one of these two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Treatment GroupExperimental Treatment2 Interventions
Group II: Control GroupActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Efficacy of Methylprednisolone for Pain Control After ACL ...

The purpose of this study is to investigate the impact of adding a methylprednisolone taper to the pain regimen after ACL repair surgery to ...

The efficacy and safety of methylprednisolone for pain ...

Methylprednisolone could significantly decrease postoperative pain score, narcotic consumption and opioid-related adverse effects after TKA.

Efficacy of Preemptive Dexamethasone versus ... - PMC

We conducted this review to evaluate the effectiveness of dexamethasone versus methylprednisolone in reducing postoperative outcomes after M3M surgery.

Efficacy of Methylprednisolone for Pain Control After ACL ...

The purpose of this study is to investigate the impact of adding a methylprednisolone taper to the pain regimen after ACL repair surgery to determine if this ...

Liposomal Bupivacaine Decreases Post-Operative Opioid ...

Liposomal bupivacaine is effective in decreasing post-operative opioid use and reducing post-operative pain scores as compared to traditional ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31743165/

Methylprednisolone Does Not Reduce Acute Postoperative ...

There are currently no data to suggest that methylprednisolone has significant analgesic benefit in adults having cardiac surgery.

Efficacy and safety of steroid use for postoperative pain ...

Outcomes data suggest that postoperative oral steroid may reduce postoperative pain but does not necessarily decrease short-term opioid use after lumbar ...