Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
Neural injury is a well-known complication following extreme lateral lumbar interbody fusion (XLIF). It has been found that up to 9.4% of patients will have either temporary or persistent neurologic deficit. This occurs with traversal of the psoas muscle or direct injury to lumbosacral plexus or sympathetic ganglion. While often temporary, it can cause hip flexor weakness, thigh numbness, or pain.
Several studies have demonstrated reduced patient reported pain scores following steroid administration, particularly in the early postoperative period. However, few studies have investigated the efficacy of intraoperative local injection of corticosteroid in reducing the incidence and duration of postoperative pain or neurologic injury for XLIF patients.
详细描述
The purpose of this study is to determine if the incidence and duration of postoperative pain is reduced in the subjects receiving a local injection of methylprednisolone when compared to placebo following XLIF.
The investigators hypothesize that subjects undergoing XLIF who receive local methylprednisolone will have:
- Reduced incidence and duration of postoperative pain and neurologic injury
- Shorter hospital stay
- Better short- and long-term outcomes
The study also aims to answer the following questions:
- Do subjects who receive local corticosteroids have a reduced incidence and duration of postoperative pain and neurologic deficit compared to those who receive placebo?
- Do subjects who receive local corticosteroids have a reduced hospital stay compared to those who received placebo?
- Is local corticosteroid therapy associated with improved short and long-term outcomes?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing a 1- to 2-level XLIF
- •Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
- •Patients able to provide informed consent
排除标准
- •Allergies or other contraindications to medicines in the protocol including:
- •Existing history of gastrointestinal bleeding
- •Lumbar spine trauma
- •Unable to speak, read, or understand English
研究组 & 干预措施
Local injection of methylprednisolone
Drug: methylprednisolone Injection of 80mg methylprednisolone injectable suspension at surgical site prior to incision closure
干预措施: Methylprednisolone (Drug)
Local injection of saline
Administration of saline at surgical site prior to incision closure.
干预措施: Saline (Drug)
结局指标
主要结局
Postoperative Pain
时间窗: 2 year postoperative
Change in Visual Analogue Scale (VAS) Back and Leg pain score from preoperative value will be assessed. VAS back and leg pain scores assess pain in each region on a scale from 0-10 with 0 being no pain and 10 being worst pain imaginable.
次要结局
- Disability(2 year postoperative)
- Narcotic Consumption(2 year postoperative)
- Length of Stay(1 week postoperative)
- General health status(2 year postoperative)
- Physical Functioning(2 year postoperative)
- Post-operative adverse events(1 week postoperative)
研究者
Kern Singh
Professor, Department of Orthopaedic Surgery
Rush University Medical Center