The Influence of Needle-insertion Depth on Successful Epidurogram and Clinical Outcome in Caudal Epidural Injections: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- the incidence of intravascular injection
研究概览
简要总结
Caudal epidural injections have been commonly performed in patients with low back pain and radiculopathy. Conventional caudal epidural injections, which the needle is advanced into the sacral canal, present a potential risk of penetration of the epidural venous plexus or dura. The investigators hypothesized that a new caudal injection technique, which the needle only penetrates the sacrococcygeal ligament without being inserted into the sacral canal, might represent a safe alternative, with a lower incidence of intravascular injections and patient's discomfort during the procedure than the conventional technique. The study is designed to investigate the influence of the depth of the inserted needle on successful epidurogram and clinical outcome in caudal epidural injections under the ultrasound and digital subtraction angiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (20-80 years of age) who were scheduled to receive caudal epidural injection for lumbosacral radicular pain at our pain management clinic
排除标准
- •pregnancy
- •coagulopathy
- •systemic infection
- •any active infection at the injection site
- •history of allergy to contrast media, local anesthetics, corticosteroid
- •patients unable to communicate or patients with cognitive dysfunction
研究组 & 干预措施
Group A
Conventional method group (n=85): caudal injection after advancement of the needle into the sacral canal. Ultrasound is used to achieve accurate needle placement and we will check intravascular injection using digital subtraction angiography.
Group B
New method group (n=85): same as conventional method group except caudal injection right after penetrating the sacrococcygeal ligament.
干预措施: new caudal injection technique (Procedure)
结局指标
主要结局
the incidence of intravascular injection
时间窗: 5 seconds after injection of contrast media via block needle.
the incidence of intravascular injection in the conventional method group and the new method group during the caudal epidural injections.
次要结局
未报告次要终点