Study of the Use of Ultrasound Scan for Lumbar Regional Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Number of Participants With Successful Techniques
研究概览
简要总结
The patients will be allocated to 2 groups: the ultrasound group and the palpation group. Ultrasound detection of the puncture site will be performed to the patients of the one group (group U). The puncture site will be determined by palpation of the landmarks at the patients of the other group (group L). The main purpose of the study is to determine if the ultrasound scan of the lumbar spine can facilitate spinal, epidural and combined spinal-epidural anesthesia, increase the success and decrease the complication rate of these techniques. The secondary purpose of the study is to evaluate if the lumbar ultrasound scan can be used to determine accurately the depth of the epidural space.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery under spinal, epidural or combined spinal-epidural anesthesia.
- •Surgery under general anesthesia and preoperative placement of epidural catheter for postoperative analgesia.
排除标准
- •History of lumbar spinal surgery.
- •Low back pain at the time of anesthesia
结局指标
主要结局
Number of Participants With Successful Techniques
时间窗: An expected average of 10 minutes after the technique.
For spinal and epidural anesthesia, success of the technique is defined as the installation of sensory block before surgery. For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.
Repositioning Frequency.
时间窗: An expected average of 10 minutes after the technique.
How many times did the operator change the trajectory of the needle.
Number of Participants With Change of the Intervertebral Space.
时间窗: An expected average of 10 minutes after the technique.
Number of patients to whom the operator had to perform the puncture at a different intervertebral place than the initial one.
Number of Participants With Success of the Technique at the First Attempt
时间窗: An expected average of 10 minutes after the technique.
Number of patients with completion of the technique without any withdrawal or reposition of the needle.
Number of Attempts Required.
时间窗: An expected average of 10 minutes after the technique..
How many times did the operator withdraw the needle and repeated the puncture.
Time Required.
时间窗: An expected average of 15 minutes.
Time passed from the positioning of the patient on the table until the end of the neuraxial anesthesia
次要结局
- Depth of the Epidural Space Measured by Ultrasound.(An expected average of 3 minutes after the beginning of the procedure.)
- Low Back Pain Intensity.(12hours and 24hours after the end of the technique.)
- Number of Patients With Low Back Pain.(12hours and 24hours after the end of the technique.)
- Depth of the Epidural Space Measured by the Needle.(An expected average of 5 minutes after the beginning of the procedure.)
- Patient Satisfaction.(12hours after the end of the technique.)
- Number of Participants With Any Complication.(24hours after the end of the technique.)
研究者
Georgios Kotsovolis
Doctor
424 General Military Hospital