Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

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