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临床试验/NCT02616653
NCT02616653已完成不适用

Identification of the L3-L4 Intervertebral Space in Obese Parturients at Term in the Sitting and Lateral Positions: Manual Palpation (Tuffier's Line Method) Versus Ultrasound Imaging

Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Estimation of Tuffier's line using the palpation method

研究概览

简要总结

This study is designed to determine the frequency of Tuffier's line overestimation (2 lumbar levels or more) when the palpation method is used in obese parturients at term in the lateral position compared to the sitting position.

Hypothesis: The L3-L4 intervertebral space identified by the palpation method will be two levels higher than the level determined by ultrasonography (US) more often in the lateral than in the sitting position.

详细描述

For years now, anesthesiologists have used anatomical landmarks to guide neuraxial anesthesia and analgesia techniques in obstetric patients. Traditionally, Tuffier's line (intercristal line) has been used as a reference and corresponds to a horizontal line drawn between the upper part of the iliac crests that is thought to intersect the spine at the level of the L4 spinous process or the L4-L5 intervertebral space. However, many studies have found this anatomical landmark to be unreliable reporting the Tuffier's line to intersect the spine at levels ranging from the L3-L4 to L5-S1 intervertebral spaces. Regarding the obstetrical population, the anatomical position of the Tuffier's line was found to be even higher presumably due to the exaggerated lordosis of pregnancy.

Neuraxial techniques used for obstetrical anesthesia and analgesia include epidurals, spinals and combined epidural-spinal (CSE) techniques. The correct identification of the intervertebral space for neuraxial analgesia and anesthesia is very important especially if using a spinal injection such as is done when performing a CSE.

Neuraxial techniques can be done in the sitting or the lying lateral position. When expecting a more challenging technique, such as in an obese patient, anesthesiologists will usually choose to perform the technique with patients in the sitting position. But the lateral position is preferred in certain conditions such as in premature rupture of membranes where there is a risk of umbilical cord prolapse, in women experiencing a vasovagal response caused by the needle insertion or upon assuming the sitting position, or because of the anesthesiologist's preference.

US-guided regional techniques are gaining popularity both for the general population as well as for the pregnant women. It has been shown to be a more reliable tool than the palpation method in identifying a specific lumbar intervertebral level. The use of US imaging for neuraxial techniques in pregnant women has been shown to reduce the numbers of attempts, improve the comfort of the patient during the procedure and increase the precision in identifying the intervertebral space at which the technique is being performed. Obesity can make regional techniques extremely challenging and US imaging becomes a valuable tool in this setting.

Methods:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Obese pregnant women (BMI equal or superior to 30)
  • Pregnancy at term (37 weeks or more)

排除标准

  • American Society of Anesthesiologists' physical status of 4 or 5
  • Scoliosis or any other anomaly of the spine
  • Prior spine surgery
  • Inability to assume the correct position due to back pain
  • Inability to collaborate
  • Labouring women

结局指标

主要结局

Estimation of Tuffier's line using the palpation method

时间窗: On Day one during medical appointment at the obstetrics clinic

Incidence of overestimation of the Tuffier's line (2 lumbar levels or more) using the palpation method in the sitting position compared to the lateral position

次要结局

  • Impact of fundal height on estimation of the Tuffier's line using the palpation method(On Day one during medical appointment at the obstetrics clinic)
  • Comfort level using a verbal rating scale(On Day one during medical appointment at the obstetrics clinic)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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