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

2014147

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.

2019-11-21

2025-10-01

2025-10-01

Recruiting

Early phase I

200

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The patient will be blinded to which arm they were assigned. This will be accomplished by the research coordinator determining the randomization status and passing this information along to a surgical nursing staff. The nurse will the procure either the placebo or treatment drug and give it to the treating physician and announce which treatment drug the patient is receiving.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-03-27