Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- Postoperative Pain
研究概览
简要总结
The purpose of this study is to determine if the frequency and duration of postoperative pain are improved in participants receiving a local steroid injection (methylprednisolone) plus a systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving a systemic (IV) steroid (dexamethasone) alone. Both of these steroid injections are already currently used at Rush and are considered standard of practice. It is well established that steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is routinely used in many types of surgery, but it is not known whether two steroids are better than one. The medications provided in this study are approved by the Food and Drug Administration (FDA).
详细描述
Postoperative pain is a well-known complication following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). It has been found that up to 40% of lumbar spinal patients will have either recurrent or persistent postoperative pain. Several studies have demonstrated reduced patient reported pain scores following steroid administration. However, few studies have investigated intraoperative local injection of corticosteroid at the surgical site in an effort to reduce the incidence and duration of postoperative pain for MIS TLIF patients.
The purpose of this study is to determine if the incidence and duration of postoperative pain is improved in participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone undergoing MIS TLIF.
The investigators hypothesize that participants undergoing MIS TLIF who receive local methylprednisolone along with the systemic dexamethasone will have:
- Reduced incidence and duration of postoperative pain compared to participants receiving only systemic dexamethasone.
- Shorter hospital stay compared to participants receiving only systemic dexamethasone.
- Better short- and long-term outcomes compared to participants receiving only systemic dexamethasone
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 primary 1- to 2-level MIS TLIF
- •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:
- •(a) Existing history of gastrointestinal bleeding
- •Current Smokers
- •Lumbar spine trauma
- •Bilateral cages
- •Lack of consent
研究组 & 干预措施
IV dexamethasone
Standard systemic (IV) dexamethasone only
干预措施: Dexamethasone (Drug)
Local Depomedrol plus IV dexamethasone
Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
干预措施: Methylprednisolone (Drug)
Local Depomedrol plus IV dexamethasone
Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Postoperative Pain
时间窗: 2 years postoperative
Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
次要结局
- Physical Functioning(2 years postoperative)
- Disability(2 years postoperative)
- General health status(2 years postoperative)
- Narcotic Consumption(1 week postoperative)
- Length of Stay(1 week postoperative)
- Intra-operative adverse events(day of surgery)
- Post-operative adverse events(1 week postoperative)
研究者
Kern Singh
Professor, Department of Orthopaedic Surgery
Rush University Medical Center