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临床试验/NCT03606525
NCT03606525Unknown不适用

Correlation Between Vertebral Column Length (VCL), Abdominal Circumference (AC) and Spread of Intrathecal Hyperbaric Bupivacaine in the Term Parturient

University of Malaya1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2018年8月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
130
试验地点
1
主要终点
sensory block level

研究概览

简要总结

Currently there is no guideline to decide on the most appropriate dose of spinal anaesthesia. This study is planned to find out factors that influence the effect of spinal anaesthesia in pregnant mother going for Caesarean section and both the mother and baby's outcomes. Investigators will recruit pregnant mothers who are planned for elective Caesarean section under spinal anaesthesia at University Malaya Medical Centre before operation and obtained their consent to participate in this study. Routine standard care will be provided for all the participants. Perioperative data including vertebral column length and abdominal girth measured by measuring tape will be collected and analysed. There is no new intervention performed on participants.

详细描述

The rising rate of caesarean section is a global phenomenon. Rate of caesarean section in Malaysia were 23.41% in 2011 and 25.08% in 2012. Subarachnoid block is the preferred anaesthetic technique for most lower segment caesarean section as compared to general anaesthesia. This is because general anaesthesia is associated with higher risk of failed endotracheal intubation and aspiration of gastric contents in parturients. Moreover, usage of pencil-point spinal needle had reduced the risk of postdural puncture headache frequency and severity.

Effective surgical anaesthesia is the main objective of subarachnoid block. Therefore, adequate sensory blockade with minimal maternal and neonate side effects are warranted. The suitable level of sensory blockade post subarachnoid block for lower segment caesarean section is bilateral block up to T6 dermatome level to pinprick. This will block the somatic sensation and eliminate the visceral pain from peritoneal manipulation during caesarean section.

However, the spread of subarachnoid block may be variable. Various patient variables such as age, height, weight, body mass index, vertebral column length and abdominal girth influence the spread of subarachnoid block. Inadequate sensory blockade will cause parturient suffer from pain while excessive blockade will lead to unwanted sympathetic inhibition causing hypotension and bradycardia. Ability of an anaesthetist to determine optimal dose to achieve adequate level of sensory blockade yet with minimal unwanted side effects is crucial.

Incidence of maternal hypotension is related to the level of sensory blockade after subarachnoid block.And maternal hypotension is associated with maternal discomfort during caesarean section and poorer fetal outcomes. Therefore, this study is carried out to investigate whether vertebral column length and abdominal circumference affecting the spread of intrathecal hyperbaric bupivacaine in term parturient.

Previous studies showed conflicting results on the factors that influence the effect of spinal anaesthesia. One of the studies was carried out in China which might not reflect the investigator's local multiracial population characteristics. Previous studies also did not investigate the outcome of baby related to maternal hypotension which is known complication.

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

入选标准

  • patients aged more than 18 years old
  • American Society of Anesthesiologists (ASA) physical status I-II
  • singleton pregnancy
  • gestational age 37 weeks or more
  • height 150-175cm and weight 50-100kg

排除标准

  • patients with contraindication to subarachnoid block
  • history of allergy to local anaesthetics
  • contraindication to NSAIDS use
  • failure of subarachnoid block
  • any abnormality of spine
  • history of spinal surgery
  • refusal to participate in this research

结局指标

主要结局

sensory block level

时间窗: 15 minutes after subarachnoid injection

Pin-prick test will be performed in both midclavicular lines to determine to level of sensory blockade every 3 minutes. Highest level of sensory blockade will record at 15 minutes after intrathecal injection.

次要结局

  • blood pressure post subarachnoid block(2 hours)
  • regression of subarachnoid block(1day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Soo Suet Ker

Medical officer, Department of Anaesthesiology, Principal investigator

University of Malaya

研究点 (1)

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