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临床试验/CTRI/2024/02/062990
CTRI/2024/02/062990尚未招募不适用

Study of correlation of anthropometric measurements and spread of spinal anaesthesia in parturiants undergoing caesarean section – A Prospective Observational Study

D Y Patil University School Of Medicine1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2024年2月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
136
试验地点
1
主要终点
To study the effect of abdominal circumference - measured at the level of umbilicus , vertebral length - measured from C7 vertebra to the sacral cornu, hip/shoulder width on sensory level of spinal anesthesia

研究概览

简要总结

Spinal anesthesia is widely used in parturients for cesarean section.Plain bupivacaine is often used for spinal anesthesia. However, the intrathecal spread of plain bupivacaine is highly unpredictable.Patient characteristics such as height, weight, and body mass index are frequently used to predict spinal anesthesia spread, but the results have been unsatisfactory.Certain anthropometric measurements that are practically obtainable may explain the variability in the spread of spinal anesthesia to some extent.These can be useful to clinicians for quick assessment of the spread of sensory level of spinal anesthesia in individual patients to avoid the risk of high block and also an inadequate level of block. All of the term parturients will be kept nil per oral for 8 h before the cesarean section.Parturient will be placed on a horizontal operating table in the supine position, and during the end of expiration, the abdominal girth will be measured at the level of the umbilicus. While the parturient is sitting on the operating table with a straightened back  ,VCL will be measured from the middle of the C7 vertebra to the sacral hiatus and hip‑width is measured between the two iliac crests, shoulder‑width is measured between two acromion processes.

A total of 2mL of 0.5% plain bupivacaine is injected intrathecally over a period of 10 seconds when free flow of CSF is obtained. After the spinal injection, the patients will be immediately returned to the supine position.

The spinal spread will be assessed in  midclavicular line every 2 minutes using a 23-gauge needle for loss of pinprick sensation , continued till there will be  no further increase in three consecutive observations. Time to achieve the maximum sensory level will be defined as the time between the intrathecal injection and loss of pinprick sensation to that level.

Correlation and linear regression analysis will be used to analyse whether any relation exists between the highest level of sensory blockade achieved and the parturients’ VCL, Shoulder/hip width and abdominal circumference.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1.All patients giving consent 2.American Society of Anesthesiology physical status Class I or II 3.All term parturiants aged 20-40 years, and who were scheduled for elective C/S under spinal anesthesia.

排除标准

  • 1.All patients giving consent
  • American Society of Anesthesiology physical status Class I or II, 3.All term parturiants aged 20-40 years, and who were scheduled for elective C/S under spinal anesthesia.

结局指标

主要结局

To study the effect of abdominal circumference - measured at the level of umbilicus , vertebral length - measured from C7 vertebra to the sacral cornu, hip/shoulder width on sensory level of spinal anesthesia

时间窗: at the time of spinal anesthesia and every 2 minutes till the first 20minutes

次要结局

  • Incidence of hypotension and bradycardia during cesarean section caused due to the effect of spinal anesthesia(at the time of spinal anesthesia and every 2 minutes till 20minutes after blockade)

研究者

发起方
D Y Patil University School Of Medicine
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Fayaz Sultan

D Y Patil University School Of Medicine

研究点 (1)

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