RecruitingPhase 4NCT04182997

Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy

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


Sponsor

University of Missouri-Columbia

Enrollment

200 participants

Start Date

Nov 21, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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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Interventions

DRUGDexamethasone

Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.

DRUGsaline 0.9%

Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.


Locations(1)

Missouri Orthopaedic Institute

Columbia, Missouri, United States

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NCT04182997


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