Comparison of Echo-assisted ALR (Loco-regional Anesthesia) Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient Performed by an Anesthesia Resident
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- the rate of FNP (thus atraumatic puncture)
研究概览
简要总结
This is a randomized, open-label, single-center clinical trial. The purpose of the study is to understand whether the aid of ultrasound assessment is useful in improving the competence of resident.
Specifically, to demonstrate how the aid of echo-assistance in the evaluation of the spine increases the atraumatic success rate (primary objective) and reduces the number of complications (particularly, the number of attempts needed and the rate of dura puncture) (secondary objective) in physicians in specialty training.
Pregnant patients requiring peridural analgesia will be assigned to the intervention or control group by simple randomization.
详细描述
The use of echo-assisted assessment has been studied for about a decade, showing encouraging results as far as experienced medical personnel are concerned, but to date, a systematic study assessing the usefulness of this aid in improving residents' competence (as indicated by the 2019 systematic review) is lacking in the literature.
To date, echo-assisted assessment is not routinely applied to all obstetric patients, as it is a relatively new technique and not yet widely used by all anesthesiologists.
If the results of the study are positive,echo-assisted assessment use could be expanded, reducing the number of complications and increasing the number of atraumatic epidural catheter placements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients >18 years of age with no BMI (Body Mass Index) limitation
- •Pregnant patients requiring partoanalgesia
- •Obtaining informed consent for study participation
排除标准
- •Patients with contraindications to epidural catheter placement
- •Endocranial hypertension
- •Coagulopathies
- •Severe thrombocytopenia < 75,000 per mm^3.
结局指标
主要结局
the rate of FNP (thus atraumatic puncture)
时间窗: Through study completion,an average of 1 year
The primary objective of this study is to demonstrate whether or not the aid of echo-assistance in spinal evaluation, performed by an experienced anesthesiologist, increases the atraumatic success rate, First Needle Pass (FNP), in epidural catheter placement by inexperienced personnel (physicians in specialty training, MFS). This objective will be calculated by observing the rate of FNP (thus atraumatic puncture).
次要结局
- Change the number of complications(Through study completion,an average of 1 year)