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

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04182997

Collaborator

(none)

200

Enrollment

Location

Arms

46.3

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Disc Herniation	Drug: Dexamethasone Drug: saline 0.9%	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Participant)

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 21, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Group Patients in this group will be given the placebo (sterile saline).	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. Other Names: sterile saline
Active Comparator: Dexamethasone Group Patients in this group will be given the study drug (dexamethasone).	Drug: Dexamethasone Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery. Other Names: Decadron

Arm

Intervention/Treatment

Placebo Comparator: Placebo Group

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

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.

Other Names:

sterile saline

Active Comparator: Dexamethasone Group

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

Drug: Dexamethasone

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

Other Names:

Decadron

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Casey A Fogarty	Columbia	Missouri	United States	65202

Sponsors and Collaborators

University of Missouri-Columbia

Investigators

Principal Investigator: Don Kim Moore, MD, Missouri Orthopaedic Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Don Moore, MD, Assistant Professor, Orthopedic Surgery, University of Missouri-Columbia

ClinicalTrials.gov Identifier:

NCT04182997

Other Study ID Numbers:

2014147

First Posted:

Dec 2, 2019

Last Update Posted:

Dec 6, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Intervertebral Disc Displacement

Dexamethasone

Study Results

No Results Posted as of Dec 6, 2021