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临床试验/CTRI/2024/07/071013
CTRI/2024/07/071013招募中不适用

Sacral anatomical interspace landmark (SAIL) technique Vs classical intercristal line landmark (CILL) technique- a prospective diagnostic study for accurate identification of lumbar intervertebral space in parturients.

Post-Graduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
106
试验地点
1
主要终点
Compare the accuracy in identifying L4-L5 intervertebral space with SAIL technique Vs CILL technique in parturients.

研究概览

简要总结

This study is a prospective diagnostic study comparing the accuracy of Sacral Anatomical Interspace Landmark (SAIL) technique Vs Classical Intercristal Line Landmark (CILL) technique to identify L4-L5 intervertebral space in parturients.

Preoperative evaluation of parturients will be conducted for checking eligibility as per inclusion criteria. After the written informed consent, eligible parturients will be enrolled as study participants. Participants’ demographic details, medical history and relevant general physical examination will be noted. In the labour room or ward area, participants will be asked to sit to one side of a levelled streture / patient trolley with her neck, back and hips flexed. The independent anaesthesia provider well versed with the study techniques will mark all participants’ back at the estimated L4-L5 intervertebral space using the two study techniques-The Sacral Anatomical Interspace Landmark (SAIL) Technique and The classical intercristal line landmark (CILL) technique. The sequence of techniques will be randomized using the computer-generated random number table. A lumbo-sacral spine ultrasonography experienced anaesthesia provider will scan the participants’ lumbosacral spine area with the study participant sitting in the same flexed position. He/she will check actual level of clinical estimate measurements for L4-L5 intervertebral level markings done using the CILL as well as SAIL techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Parturients with age more than 18 years, Singleton pregnancy, Gestational age more than 37 weeks.

排除标准

  • 1.Refusal to participate, 2.Non- cooperative with the required positioning, 3.History of previous spine surgery, 4.Known case of spine deformities, 5.Second and third stage of labor, 6.Morbid obesity.

结局指标

主要结局

Compare the accuracy in identifying L4-L5 intervertebral space with SAIL technique Vs CILL technique in parturients.

时间窗: Preoperative

次要结局

  • Compare the occurrence of estimated measurements falling above L3 vertebra with SAIL technique Vs CILL technique in parturients.(Preoperative)

研究者

发起方
Post-Graduate Institute of Medical Education and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nikitha Jameel

Post-Graduate institute of medical education and research

研究点 (1)

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