Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy (Intra-Op)

  • STATUS
    Recruiting
  • End date
    Oct 12, 2023
  • participants needed
    200
  • sponsor
    University of Missouri-Columbia
Updated on 19 February 2022
conservative management
dexamethasone
discectomy
radiculopathy

Summary

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.

Description

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.

Details
Condition Lumbar Disc Herniation
Treatment Dexamethasone, Saline 0.9%
Clinical Study IdentifierNCT04182997
SponsorUniversity of Missouri-Columbia
Last Modified on19 February 2022

Eligibility

Yes No Not Sure

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
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