Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy
ConditionLumbar Disc Herniation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri-Columbia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone
DrugPatients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.
saline 0.9%
DrugPatients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Placebo GroupPlacebo comparator 1 intervention
Group B: Dexamethasone GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post Operative Pain Scores
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.
Time frame
Until final follow up (up to 8 weeks)2
Post Operative Oswestry Disability Index
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.
Time frame
Until final follow up (up to 8 weeksSecondary outcomes
1
Length of stay
Determining how long patient is in hospital
Time frame
Until final follow up (up to 8 weeks)2
Post Operative Opioid Usage
comparing opioid usage post operatively
Time frame
Until final follow up (up to 8 weeks)3
Post Operative Complications
comparing rate of post-op infections
Time frame
Until final follow up (up to 8 weeks)Sponsors and contacts
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Source ClinicalTrials.gov