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临床试验/CTRI/2024/11/077361
CTRI/2024/11/077361已完成不适用

Comparative study of traditional lumbar subarachnoid block vs novel thoracic subarachnoid block for cesarean section: A randomised single blinded trial

未提供1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月2日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
To estimate the duration of motor blockade through

研究概览

简要总结

Cesarean delivery is one of the most common surgeries performed globally.Neuraxial anaesthesia is preferable to general anaesthesia for cesarean delivery as it is associated with less maternal and neonatal morbidity and mortality. Traditionally, spinal anaesthesia is administered in the lumbar region to avoid spinal cord injury. Recent MRI studies indicate a more substantial depth of the posterior subarachnoid space in the thoracic spinal cord and therefore showed no neurological sequelae at the thoracic level, and the incidence of paresthesia was similar to that seen at the lumbar level. The total amount of CSF in the thoracic segment is less when compared to the lumbar and cervical segments, causing easy blockade of roots and a reduction in the dose of the drug required, along with improved muscle relaxation. During lumbar spinal anaesthesia, the sympathetic blockade extends to the lower limbs resulting in vasodilation of the blood vessels and reduction in preload. During thoracic spinal anaesthesia, the sympathetic block is restricted to fewer dermatomes with minimal involvement of the lower limbs, therefore, a smaller reduction in preload and blood pressure is seen. Thoracic segmental spinal anaesthesia has been gaining popularity in recent times and has been successfully performed for abdominal cancer surgeries, breast surgeries, laparoscopic cholecystectomies, and nephrolithotomies. In pregnant females posted for cesarean section, thoracic spinal anaesthesia helps in early mobilisation postoperatively, which meets the goals of enhanced recovery after surgery (ERAS). It also helps with the early initiation of breastfeeding, ensuring that the infant receives colostrum while facilitating the emotional bonding between the mother and the baby. We are thus conducting this study to explore the effectiveness of performing thoracic segmental spinal anaesthesia in patients posted for elective cesarean surgery under neuraxial blockade

研究设计

研究类型
Interventional
分配方式
Other
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Age more than 18 years
  • ASAPS 2 and 3
  • Elective cases posted for Cesarean section under neuraxial anaesthesia.

排除标准

  • Refuse to consent
  • BMI more than 35 kg/m2
  • ASAPS more than 3
  • Contraindication to neuraxial block.

结局指标

主要结局

To estimate the duration of motor blockade through

时间窗: Throughout PACU stay

1. Ability of the patient to slide out of the table with flexion at the hip by the end of the surgery

时间窗: Throughout PACU stay

2. Time to be able to sit from the side of the bed with legs dangling

时间窗: Throughout PACU stay

3. Time to walk with support

时间窗: Throughout PACU stay

次要结局

  • To estimate the incidence of following perioperative outcomes:(1. Incidence of nausea, vomiting, and shivering.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Damarla Haritha

Narayana Medical College

研究点 (1)

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