Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy (Intra-Op)

University of Missouri (MU)

Status and phase: Enrolling; Phase 4

Conditions: Lumbar Disc Herniation

Treatments: Drug: Dexamethasone; Drug: saline 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT04182997

2014147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Patients in this group will be given the placebo (sterile saline).

Treatment:

Drug: saline 0.9%

Dexamethasone Group

Active Comparator group

Description:

Patients in this group will be given the study drug (dexamethasone).

Treatment:

Drug: Dexamethasone