Comparison between parasagittal oblique approach and axial approach of ultrasound guided technique in transforaminal epidural injection: A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To see dye spread pattern through both approaches
研究概览
简要总结
Transforaminal Epidural Injection is used for pain relief in patients of radicular lumbosacral pain under fluoroscopic guidance.(1) Fluoroscopy has various limitations like requirement of specialized equipments, technical staff and risk of radiation exposure. If the procedure can be done under USG guidance, then it would reduce radiation exposure and cost of procedure. USG guided Transforaminal epidural injection has been tried in both axial and parasagittal oblique approach with fluoroscopic or CT confirmation.(2) Previously both techniques have not been compared with respect to dye spread. Therefore this study aims to compare the dye spread pattern of the two approaches.
1. Patel K, Chopra P, Martinez S, Upadhyayula S. Epidural Steroid Injections. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 [cited 2024 Nov 10]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK470189/
2. Soni P, Punj J. Ultrasound-Guided Lumbar Transforaminal Epidural Injection: A Narrative Review. Asian Spine J. 2021 Apr;15(2):261–70.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed case of unilateral lumbosacral radicular pain not involving more than 2 dermatomes at either levels of L3 L4 L5, ASA I and II, Pain lasting more than three months, NRS more than 5 after administrating medical management.
排除标准
- •patient with any known allergy to local anesthesia, pregnancy, neurological or psychiatric disease on concurrent medication, local site infection/sepsis/bacteremia, coagulation disorder, spinal tumors/spinal tuberculosis/spinal deformity, symptoms of severe nerve damage including motor paralysis/muscle atrophy/peripheral neuropathy/arterial vascular disease/malignancy/cauda equina syndrome.
结局指标
主要结局
To see dye spread pattern through both approaches
时间窗: immediately after intervention
次要结局
- To note the needle tip positioning(immediately after completion of intervention)
- Time to Procedure (scanning & needling)(immediately after completion of intervention)
研究者
Jyotsna Punj
All India Institute of Medical Sciences, New Delhi