Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy
- Registration Number
- NCT04182997
- Lead Sponsor
- University of Missouri-Columbia
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group saline 0.9% Patients in this group will be given the placebo (sterile saline). Dexamethasone Group Dexamethasone Patients in this group will be given the study drug (dexamethasone).
- Primary Outcome Measures
Name Time Method Post Operative Oswestry Disability Index Until final follow up (up to 8 weeks 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.
Post Operative Pain Scores Until final follow up (up to 8 weeks) 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.
- Secondary Outcome Measures
Name Time Method Length of stay Until final follow up (up to 8 weeks) Determining how long patient is in hospital
Post Operative Opioid Usage Until final follow up (up to 8 weeks) comparing opioid usage post operatively
Post Operative Complications Until final follow up (up to 8 weeks) comparing rate of post-op infections
Trial Locations
- Locations (1)
Missouri Orthopaedic Institute
🇺🇸Columbia, Missouri, United States