Randomized Controlled Clinical Study to Validate the Clinical Accuracy and Safety of Biplanar Ultrasound-guided Puncture of Lumbar Interforamen in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- number of radiographies
研究概览
简要总结
The goal of this clinical trial is to compare Xplane ultrasound with radiography for guidance of lumbar interforamen puncture in patients with lumbar disc herniation. The main question[s] it aims to answer are:
- The feasibility that the Xplane ultrasound assists surgeon in mastering lumbar interforamen puncture faster than radiography.
- The clinical accuracy and safety of the Xplane ultrasound-guidance lumbar interforamen puncture faster.
Participants will undergo lumbar interforamen puncture with guidance of Xplane ultrasound or radiography. If there is a comparison group: Researchers will compare the first success rate, number of punctures, number of radiographies, puncture time and operator confidence score.
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
- None
盲法说明
There are practical differences in operation and blind methods cannot be achieved.
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 to 80 years of age;
- •symptoms and confirmatory signs of lumbar radiculopathy that persisted for at least 6 weeks;
- •LDH at a corresponding level and side on imaging;
- •surgical candidates for epidural steroid injection (ESI) or percutaneous endoscopic lumbar discectomy (PELD). If the patient underwent ESI and PELD surgery on the same day, we only selected the data for the first one.
排除标准
- •other diseases affecting the spine (tumor, infection, metabolic disease, immune system disease and fractures);
- •body mass index (BMI) greater than 32 kg/m2;
- •refusal to participate;
- •severe mental illnesses in the trial.
研究组 & 干预措施
Xplane ultrasound group
The lumbar interforamen puncture was performed under the guidance of Xplane ultrasound with a X6-1 volume transducer probe (frequency range 1-6MHz, center frequency 3.2MHz).
干预措施: Real-time 3D Xplane ultrasound (Device)
radiography group
The lumbar interforamen puncture was performed under the guidance of radiography with Mobile X-ray Image System (Arcadis Orbic 3D, Siemens, Germany) .
结局指标
主要结局
number of radiographies
时间窗: during operation
number of radiographies during punctures
puncture time
时间窗: during operation
how long hands are in contact with the needle
number of punctures
时间窗: during operation
number of punctures of the target
the first success rate
时间窗: during operation
the incidence of success on the first puncture of the target
次要结局
- operator confidence score(Immediately after puncture)
- operative time(Immediately after surgery)
- satisfaction of patients(1 month after surgery)
- incidence of puncture relevant complications(The patient was examined for neurovascular injury immediately after the puncture. Other complications were observed 1 month after surgery)
研究者
Yi Mao
clinician
Chinese PLA General Hospital