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NCT Number: NCT04182997

Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Missouri Orthopaedic Institute

Columbia, Missouri, 65202, United States

Location status: Recruiting

Location contact

Don Moore, MD

PRINCIPAL_INVESTIGATOR

Theodore Choma, MD

SUB_INVESTIGATOR

Vicki Jones, MEd,CCRP

CONTACT

[email protected]

573-882-7583

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Other names: Decadron

saline 0.9%

Drug

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

Other names: sterile saline

Primary outcomes

  1. Post Operative Pain Scores

    Time frame: 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.

  2. Post Operative Oswestry Disability Index

    Time frame: 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 outcomes

  1. Length of stay

    Time frame: Until final follow up (up to 8 weeks)

    Determining how long patient is in hospital

  2. Post Operative Opioid Usage

    Time frame: Until final follow up (up to 8 weeks)

    comparing opioid usage post operatively

  3. Post Operative Complications

    Time frame: Until final follow up (up to 8 weeks)

    comparing rate of post-op infections

Study contacts

Contact information is provided by the study sponsor or research team.

Vickci Jones, MEd, CCRP

CONTACT

[email protected]

(573) 882-7583

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy for Herniated Lumbar Discs Is There a Role? - A Randomized Control Trial

Acronym: Intra-Op

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2019
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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