A Novel Method of Improving Accuracy of Anatomical Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Accuracy, as measured by percentage of estimations that correctly match ultrasound determined interspace
研究概览
简要总结
This study is a randomized clinical trial to evaluate the accuracy of the novel SAIL technique compared to the classic intercristal line technique in estimating the L4-L5 interspace for labor epidural or spinal anesthesia placement. The investigators hypothesize that the SAIL technique will be more accurate in successfully locating the L4-L5 interspace in pregnant women than the classic intercristal line technique.
详细描述
The current standard technique aiming at identifying the L4-L5 intervertebral space as a reference point before performing a neuraxial block relies on the correct clinical estimation of the intercristal line. The classic intercristal line technique uses an imaginary line that intersects the iliac crests to determine a safe puncture level to access. In pregnant women, the classic technique fails to identify the safe puncture level 40 % of the time.
The newly proposed Sacral Anatomical Interspace Landmark (SAIL) technique consists of using the sacral bone to determine a safe puncture level to access.
Lumbar ultrasound will determine the accuracy of each clinical technique in identifying the L4-L5 interspace (target).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
The estimation marks from each technique (two total) will be on the back of the patient (one on the left flank, one on the right flank), therefore the patient does not know where the marks are. Additionally, each mark will be covered with a taped on gauze pad to conceal it so that the two investigators are blinded to each others assessment. The ultrasound clinician will be masked to the two estimations. The marks will still remain covered while the interspace is determined by the third assessor using lumbar ultrasound.
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
- •Ultrasound-determined gestation age greater than or equal to 37 weeks
- •Expressed interest or indication for epidural anesthesia
- •Patients in the first stage of labor
排除标准
- •Patients perceived or indicating that she is unable to cooperate with positioning
- •BMI greater than 45 kg/m2
- •Previous spine surgery or known spinal deformities
- •Impaired decision making abilities
- •non-English speaking
结局指标
主要结局
Accuracy, as measured by percentage of estimations that correctly match ultrasound determined interspace
时间窗: From enrollment to the end of data collection, approximately 15 minutes
Percentage of trials for the novel and classic technique respectively that the estimation correctly matches the L4-L5 interspace as determined by lumbar paramedian ultrasound will serve as a measure of accuracy
次要结局
未报告次要终点
研究者
Carlo Pancaro
Director of Obstetrical Anesthesiology
University of Michigan