Clinical trial NCT04182997: Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy
Official title: Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy for Herniated Lumbar Discs Is There a Role? - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Lumbar Disc Herniation
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Post Operative Pain Scores
timeFrame: Until final follow up (up to 8 weeks)
measure: Post Operative Oswestry Disability Index
timeFrame: Until final follow up (up to 8 weeks
Secondary outcomes:
measure: Length of stay
timeFrame: Until final follow up (up to 8 weeks)
measure: Post Operative Opioid Usage
timeFrame: Until final follow up (up to 8 weeks)
measure: Post Operative Complications
timeFrame: Until final follow up (up to 8 weeks)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
Study officials:
affiliation: Missouri Orthopaedic Institute
name: Don Kim Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akinduro OO, Miller BA, Haussen DC, Pradilla G, Ahmad FU. Complications of intraoperative epidural steroid use in lumbar discectomy: a systematic review and meta-analysis. Neurosurg Focus. 2015 Oct;39(4):E12. doi: 10.3171/2015.7.FOCUS15269.
citation: Aljabi Y, El-Shawarby A, Cawley DT, Aherne T. Effect of epidural methylprednisolone on post-operative pain and length of hospital stay in patients undergoing lumbar microdiscectomy. Surgeon. 2015 Oct;13(5):245-9. doi: 10.1016/j.surge.2014.03.012. Epub 2014 Jun 7.
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