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Depo-Medrol for Postoperative Pain

Phase 4

Recruiting

Led By Hardeep Singh, M.D.

Research Sponsored by Hardeep Singh

Eligibility Criteria Checklist

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

Must have

Patients with lumbar disc degeneration

Transpsoas (PTP or LTP) lateral lumbar interbody fusion (LLIF) 1-3 disc levels with posterior instrumentation (Open or MIS) with or without laminectomy, must include L3-4 and/or L4-5

Must not have

Spondylolisthesis >Grade 1

Patients requiring bilateral transpsoas approaches

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year and 2 years

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing whether an injection of a steroid called Depo-medrol can help reduce hip and thigh pain after a specific type of back surgery. The goal is to see if this injection can make recovery easier for patients by reducing pain and weakness in the hip area. Depo-medrol, a corticosteroid, has been used in various medical contexts to reduce pain and inflammation, including postoperative settings.

Who is the study for?

This trial is for adults aged 18-75 with lumbar disc degeneration who are undergoing a specific back surgery (LLIF) involving the L3-4 and/or L4-5 spinal levels. Candidates must not have severe spine curvature, advanced spondylolisthesis, flatback deformity, diabetes requiring insulin, or be chronic oral steroid users. They also can't have allergies to steroids like Depo-Medrol.

What is being tested?

The study tests whether injecting Depo-Medrol into the psoas muscle after LLIF surgery reduces postoperative hip flexor weakness and thigh pain/numbness. It compares this treatment against Gel-Flow NT to see which is more effective in managing these symptoms.

What are the potential side effects?

Depo-Medrol may cause side effects such as increased blood sugar levels, weakened bones, weight gain, water retention, mood swings or changes in behavior. The severity of side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have degeneration in my lumbar disc.

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I had a specific spine surgery involving L3-4 and/or L4-5 levels.

Exclusion Criteria

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

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My spine condition is more severe than a mild slip.

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I need surgery on both sides of my spine through the psoas muscle.

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I am unable to give consent by myself.

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I have pain in the same side of my hip.

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I am scheduled for or have had a revision fusion surgery.

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I have a flatback deformity.

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I have a curve in my spine greater than 10 degrees.

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I regularly take oral steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.

Secondary study objectives

Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection.

Quantify the difference in rates of postoperative thigh numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.

Quantify the difference in severity of postoperative hip flexor weakness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.

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