Prospective Observational Study: Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 563
- 试验地点
- 1
- 主要终点
- Incidence of Difficulty of epidural catheter placement
研究概览
简要总结
This is a prospective observational study conducted at the University Hospital of Padua. The goal is to identify ultrasound markers that can help predict whether placing an epidural catheter during labor will be difficult. Pregnant women who request epidural analgesia will undergo a quick ultrasound scan of their lower back before the procedure. The study will collect information such as age, weight, height, and spinal anatomy, as well as ultrasound measurements. This information will be compared with how easy or difficult it was to place the epidural. The study does not involve any experimental treatment and uses standard care procedures already in place. There are no additional risks or costs for participants.
详细描述
This is a single-center, prospective observational study aimed at evaluating whether specific ultrasound measurements of spinal structures in pregnant women can predict technical difficulty in placing an epidural catheter during labor analgesia. All procedures performed are part of standard care and are routinely offered in the labor and delivery unit. Patients who consent to participate will undergo a lumbar ultrasound prior to epidural catheter placement. Data will be collected regarding anatomical and clinical characteristics, ultrasound findings, and procedural details. The study will run for two years or until the estimated sample size of 563 patients is reached. The results are intended to identify non-invasive predictors of challenging epidural placement, potentially improving patient safety and resource allocation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged ≥18 years Candidates for epidural catheter placement for labor analgesia Provided written informed consent
排除标准
- 未提供
结局指标
主要结局
Incidence of Difficulty of epidural catheter placement
时间窗: Periprocedural
Defined as the need for more than one puncture attempt (exiting the skin with the needle) or the involvement of a second operator to successfully place the epidural catheter.
次要结局
- Number of puncture attempts(Periprocedural)
- (Predictor of difficult Epidural) Distance from skin to spinous process at epidural placement level(Periprocedural)
- (Predictor of difficult Epidural) Distance between spinous processes(Periprocedural)
- (Predictor of difficult Epidural) Distance from skin to transverse process(Periprocedural)
- (Predictor of difficult Epidural) Patient age(Baseline)
- (Predictor of difficult Epidural) Pre-pregnancy weight(Baseline)
- (Predictor of difficult Epidural) Current weight(Baseline)
- (Predictor of difficult Epidural) Body Mass Index (BMI)(Baseline)
- (Predictor of difficult Epidural) Palpability of spinous processes(Periprocedural)
- (Predictor of difficult Epidural) Previous spinal surgery(Baseline)
- (Predictor of difficult Epidural) Presence of scoliosis(Baseline)
- (Predictor of difficult Epidural) Operator Experience(Periprocedural)
研究者
Alessandro De Cassai
Principal Investigator
University of Padova