Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04182997
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Missouri-Columbia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Don Kim Moore, MD
Principal Investigator Affiliation	Missouri Orthopaedic Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lumbar Disc Herniation

Additional Details

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.

Arms & Interventions

Arms

Placebo Comparator: Placebo Group

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

Active Comparator: Dexamethasone Group

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

Interventions

Drug: - Dexamethasone

Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.

Drug: - saline 0.9%

Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Missouri Orthopaedic Institute, Columbia, Missouri

Status

Recruiting

Address

Missouri Orthopaedic Institute

Columbia, Missouri, 65202

Site Contact

Vicki Jones, MEd,CCRP

[email protected]

573-882-7583

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