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
NCT Number: NCT04182997
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Columbia, Missouri, 65202, United States
Location status: Recruiting
Don Moore, MD
PRINCIPAL_INVESTIGATOR
Theodore Choma, MD
SUB_INVESTIGATOR
Vicki Jones, MEd,CCRP
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.
Other names: Decadron
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
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.
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.
Time frame: Until final follow up (up to 8 weeks)
Determining how long patient is in hospital
Time frame: Until final follow up (up to 8 weeks)
comparing opioid usage post operatively
Time frame: Until final follow up (up to 8 weeks)
comparing rate of post-op infections
Contact information is provided by the study sponsor or research team.
University of Missouri-Columbia
Other
Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy for Herniated Lumbar Discs Is There a Role? - A Randomized Control Trial
Acronym: Intra-Op
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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