Lumbar Disc Herniation
Conditions
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.
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.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTVickci Jones, MEd, CCRP
PRINCIPAL_INVESTIGATORDon Kim Moore, MD
Missouri Orthopaedic Institute
Outcome results
None listed