Use of Local Intraoperative Steroid in MIS TLIF
2020年11月18日 更新者：Kern Singh、Rush University Medical Center
Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion
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).
研究概览
详细说明
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
研究类型
介入性
注册 (实际的)
105
阶段
- 第三阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：局部去甲萘醌加静脉注射地塞米松
局部术中应用甲泼尼龙 (Depomedrol) 加标准全身 (IV) 地塞米松
|
术中静脉注射 10mg 地塞米松
Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure
|
|
安慰剂比较：IV dexamethasone
Standard systemic (IV) dexamethasone only
|
术中静脉注射 10mg 地塞米松
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Pain
大体时间：2 years postoperative
|
Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
|
2 years postoperative
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
术后不良事件
大体时间：术后1周
|
术后恶心呕吐、胃食管反流、肠梗阻、静脉血栓栓塞事件、呼吸抑制/气道损害、肾功能不全、伤口并发症、入住 ICU
|
术后1周
|
|
Physical Functioning
大体时间：2 years postoperative
|
Patient-Reported Outcomes Measurement Information System score as compared to preoperative value
|
2 years postoperative
|
|
Disability
大体时间：2 years postoperative
|
Oswestry Disability Index score as compared to preoperative score
|
2 years postoperative
|
|
General health status
大体时间：2 years postoperative
|
Short Form-12 Survey scores as compared to preoperative value
|
2 years postoperative
|
|
Narcotic Consumption
大体时间：1 week postoperative
|
The total amount of narcotic use for each subject will be recorded.
Dosages of narcotics will be converted to morphine equivalents
|
1 week postoperative
|
|
Length of Stay
大体时间：1 week postoperative
|
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.
|
1 week postoperative
|
|
Intra-operative adverse events
大体时间：day of surgery
|
Blood loss, length of surgery, procedural details, complications
|
day of surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- McGirt MJ, Parker SL, Lerner J, Engelhart L, Knight T, Wang MY. Comparative analysis of perioperative surgical site infection after minimally invasive versus open posterior/transforaminal lumbar interbody fusion: analysis of hospital billing and discharge data from 5170 patients. J Neurosurg Spine. 2011 Jun;14(6):771-8. doi: 10.3171/2011.1.SPINE10571. Epub 2011 Mar 18.
- Jamjoom BA, Jamjoom AB. Efficacy of intraoperative epidural steroids in lumbar discectomy: a systematic review. BMC Musculoskelet Disord. 2014 May 5;15:146. doi: 10.1186/1471-2474-15-146.
- Schizas C, Tzinieris N, Tsiridis E, Kosmopoulos V. Minimally invasive versus open transforaminal lumbar interbody fusion: evaluating initial experience. Int Orthop. 2009 Dec;33(6):1683-8. doi: 10.1007/s00264-008-0687-8. Epub 2008 Nov 21.
- Ranguis SC, Li D, Webster AC. Perioperative epidural steroids for lumbar spine surgery in degenerative spinal disease. A review. J Neurosurg Spine. 2010 Dec;13(6):745-57. doi: 10.3171/2010.6.SPINE09796.
- Debi R, Halperin N, Mirovsky Y. Local application of steroids following lumbar discectomy. J Spinal Disord Tech. 2002 Aug;15(4):273-6. doi: 10.1097/00024720-200208000-00002.
- Haws BE, Khechen B, Patel DV, Bawa MS, Ahn J, Bohl DD, Mayo BC, Massel DH, Guntin JA, Cardinal KL, Singh K. Impact of local steroid application in a minimally invasive transforaminal lumbar interbody fusion: results of a prospective, randomized, single-blind trial. J Neurosurg Spine. 2018 Nov 9;30(2):222-227. doi: 10.3171/2018.7.SPINE18584.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年11月13日
初级完成 (实际的)
2019年5月3日
研究完成 (实际的)
2019年5月3日
研究注册日期
首次提交
2017年10月5日
首先提交符合 QC 标准的
2017年10月10日
首次发布 (实际的)
2017年10月12日
研究记录更新
最后更新发布 (实际的)
2020年11月20日
上次提交的符合 QC 标准的更新
2020年11月18日
最后验证
2020年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 15052003
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
地塞米松的临床试验
-
Medical University of Lodz招聘中
-
Federal University of São PauloFaculdade de Ciências Médicas da Santa Casa de São Paulo未知