What is the mechanism of action of this treatment?

Intra-operative topical epidural steroids, such as dexamethasone or methylprednisolone, are commonly used to manage postoperative pain by reducing inflammation and pain at the surgical site. These steroids work by inhibiting the release of inflammatory mediators and reducing the activity of immune cells that contribute to inflammation. This mechanism is crucial for postoperative pain patients as it helps to minimize pain, reduce the need for opioid analgesics, and promote faster recovery. Additionally, other treatments like nonsteroidal anti-inflammatory drugs (NSAIDs) and local anesthetics may be used to provide further pain relief by blocking pain signals and reducing inflammation.

What side effects are associated with this type of intervention?

Common treatments for postoperative pain, such as intra-operative topical epidural steroids, NSAIDs, and local anesthetics, have several known side effects. Epidural steroid injections can cause minor adverse events like post-injection headache, nausea, and transient nerve root irritation, with rare but serious complications such as spinal hematoma and infection. NSAIDs are associated with gastrointestinal issues and an increased risk of bleeding. Local anesthetics can lead to local anesthetic systemic toxicity (LAST), particularly in high doses or highly vascular sites, and may cause chondrotoxicity when used in joint injections.

What prior FDA approvals exist?

The FDA has approved various treatments for postoperative pain management, including the use of corticosteroids. Corticosteroids like dexamethasone and triamcinolone have been studied for their efficacy in reducing inflammation and pain at surgical sites. These drugs are often used in multimodal pain management strategies, which may include local injections or topical applications during surgery. For instance, intra-operative topical epidural steroids are used to reduce inflammation and pain, contributing to decreased postoperative opioid consumption and improved recovery outcomes. These treatments are part of a broader approach to manage postoperative pain effectively and safely.

What other types of research exist?

Promising novel alternatives to intra-operative topical epidural steroids for postoperative pain management in 2024 include: 1) Genicular nerve blocks, which involve the ablation of specific nerves using radiofrequency or chemicals like local anesthetics or glucocorticoids, and have shown modest pain improvement. 2) Topical menthol, which has demonstrated rapid symptomatic improvement in neuropathic pain and could be beneficial for postoperative pain. These alternatives offer potential benefits in reducing inflammation and pain at the surgical site.

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Epidural Steroids for Back Pain

Phase 3

Recruiting

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients scheduled to undergo 1 to 2 level laminectomy

Between the ages of 18-85

Must not have

Minimally invasive surgery

Non-English speakers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month

Awards & highlights

Pivotal Trial

Summary

This trial tests if applying a steroid during back surgery helps patients recover faster and need less pain medication. It focuses on patients having a specific type of back surgery and looks at their recovery and pain levels.

Who is the study for?

This trial is for adults aged 18-85 undergoing a specific back surgery called lumbar laminectomy. It's not for those who don't speak English, have had daily opioid use in the last six months, need additional spine procedures, have chronic pain conditions, uncontrolled diabetes (A1C > 6.5), weakened immune systems, prostate issues causing urinary problems or are allergic to Depo-Medrol and steroids.

What is being tested?

The study tests if applying Depo-Medrol steroid directly to the spinal area during surgery can reduce post-surgery opioid use and improve recovery outcomes like hospital stay duration and return-to-work time compared to a placebo (no active medication).

What are the potential side effects?

Potential side effects of Depo-Medrol may include increased blood sugar levels, risk of infection due to immune system suppression, mood swings, weight gain around the face or abdomen, insomnia and potential increase in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a surgery to remove part of one or two vertebrae.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had or will have surgery with small incisions.

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I do not speak English.

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I am undergoing or have undergone a spinal fusion or revision at the same level.

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I have a long-term pain condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid consumption [Both Groups]

Opioid use total [Both Groups]

Secondary study objectives

Medical Complications [Both Groups]

Numeric Rating Pain Scale [Both Groups]

Oswestry Low Back Pain Disability Questionnaire [Both Groups]

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1: Topical SteroidExperimental Treatment1 Intervention

Group II: Group 2: Topical Normal SalinePlacebo Group1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intra-operative topical epidural steroids, such as dexamethasone or methylprednisolone, are commonly used to manage postoperative pain by reducing inflammation and pain at the surgical site. These steroids work by inhibiting the release of inflammatory mediators and reducing the activity of immune cells that contribute to inflammation. This mechanism is crucial for postoperative pain patients as it helps to minimize pain, reduce the need for opioid analgesics, and promote faster recovery. Additionally, other treatments like nonsteroidal anti-inflammatory drugs (NSAIDs) and local anesthetics may be used to provide further pain relief by blocking pain signals and reducing inflammation.

Advances in topical analgesics.