Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy for Herniated Lumbar Discs Is There a Role? - A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Post Operative Oswestry Disability Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo Group
Patients in this group will be given the placebo (sterile saline).
干预措施: saline 0.9% (Drug)
Dexamethasone Group
Patients in this group will be given the study drug (dexamethasone).
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Post Operative Oswestry Disability Index
时间窗: 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.
Post Operative Pain Scores
时间窗: 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.
次要结局
- Length of stay(Until final follow up (up to 8 weeks))
- Post Operative Opioid Usage(Until final follow up (up to 8 weeks))
- Post Operative Complications(Until final follow up (up to 8 weeks))
研究者
Don Moore, MD
Assistant Professor, Orthopedic Surgery
University of Missouri-Columbia