Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy

Study Overview
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Brief Summary
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The purpose of this study is to determine a grading system for inflammation in lumbar disc herniation and which groups, if any, benefit most from the administration of an intra-operative epidural steroid.

Detailed Description
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Intraoperative epidural administration of steroids following discectomy for herniated lumbar disc has been the topic of multiple studies in the literature. The results have been mixed, with the majority of the studies finding some benefit, but outcomes have varied drastically amongst the many studies. The aim of this study is to develop a grading scale for intraoperative assessment of nerve root inflammation to determine if this subjective assessment is an adequate indicator for response to epidural steroids following discectomy. Patients will be allocated randomly preoperatively to the intervention group versus control group. Pictures of the spinal cord and associated nerve root will be captured intraoperatively. These pictures will be scrutinized postoperatively and an inflammation grade will be assigned. The investigators will then identify if nerve roots with a higher-grade of inflammation respond differently to epidural steroid administration when compared to lesser-grades of inflammation. This will be measured with the a variety of outcome measures.

Official Title
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Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy for Herniated Lumbar Discs Is There a Role? - A Randomized Control Trial

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: saline 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a clinical assessment indicative of a lumbar disc herniation Failed conservative treatment - rest, anti-inflammatory medications, physical therapy Radiculopathy present - positive tension signs or sensory/motor neurologic deficits present Recent MRI confirming single-level lumbar disc herniation corresponding to clinical evaluation Exclusion Criteria: Concomitant spinal stenosis, segmental instability, or spondylolisthesis Previous surgery at the affected level or recurrent herniation Underlying disease that may affect response to steroids - immunocompromise, use of chronic steroids or immunosuppression Pregnancy - qualitative human chorionic gonadotropin (hCG) testing will be performed prior to enrollment Diagnosis of or symptoms concerning for cauda equina syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomly assigned to either the treatment group or the placebo group. At the end of surgery patients in the treatment group will have the surgical site lavaged with dexamethasone while patients in the placebo group will have the surgical site lavaged by sterile saline.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Patients in this group will be given the placebo (sterile saline). | Drug: saline 0.9%<br>* Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.<br>* Other names: sterile saline;|
| Active Comparator: Dexamethasone Group<br>Patients in this group will be given the study drug (dexamethasone). | Drug: Dexamethasone<br>* Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.<br>* Other names: Decadron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain Scores | Comparing post operative pain scores between treatment and placebo group. Using Visual Analogue Scale (VAS) pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life. | Until final follow up (up to 8 weeks) | 
| Post Operative Oswestry Disability Index | Comparing post operative disability scores between treatment and placebo group. Using Oswestry Disability Index (ODI) to measure a patient's permanent functional disability and low back functional outcome tools. | Until final follow up (up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Determining how long patient is in hospital | Until final follow up (up to 8 weeks) | 
| Post Operative Opioid Usage | comparing opioid usage post operatively | Until final follow up (up to 8 weeks) | 
| Post Operative Complications | comparing rate of post-op infections | Until final follow up (up to 8 weeks) |