CTRI/2024/12/078678尚未招募不适用
Evaluation of Materno-fetal Safety Profile under Segmental Spinal Anesthesia for Elective Lower Segment Caesarean Section: An Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Association of segmental spinal blockade to intraoperative materno-foetal outcome (cardiorespiratory and APGAR score) in parturient undergoing elective LSCS under spinal anesthesia at different block levels
研究概览
简要总结
| Central neuraxial anaesthesia is now preferred in over 80-95% of parturients undergoing LSCS. Lumbar segmental spinal anaesthesia (LSSA) is a simpler and easy procedure with a relatively rapid onset of the dense neuraxial blockade and avoids the need for maternal endotracheal intubation, which is a difficult procedure during pregnancy due to upper airway changes. However traditional lumbar segmental spinal anaesthesia causes extensive sympathectomy (thoracic-lumbar-sacral output, T4-S5 segments) and hypotension, which may affect uterine circulation and possibly affect the foetus. Further motor paralysis of lower limbs due to blockade of lumbar segmental spinal nerve roots results in delay in ambulation and early recovery of parturient obstructing the mother from participating in the care of their own newborn babies in the immediate post-natal period which is required for the bonding of mother & neonate. Thoracic segmental spinal anaesthesia has also been used for LSCS in high-risk obstetric patients (severe pregnancy-induced hypertension) where traditional lumbar spinal anaesthesia was contraindicated. The present study would be observational study of maternal and fetal outcomes of elective LSCS conducted under different segmental spinal anesthesia in our institute. The study would note/observe maternal (cardio-respiratory) and foetal (APGAR score and cord blood gas parameters) outcomes with regards to safety of thoracic segmental spinal anaesthesia and compare it with the outcomes of lumbar segmental spinal anesthesia. |
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Singleton term pregnancy undergoing elective LSCS under two different segmental spinal anaesthesia techniques (lower thoracic & lumbar) 2.Age between 18-40 years 3.American Society of Anaesthesiology physical grade (ASA) I and II.
排除标准
- •1.Parturient undergoing LSCS under any other modality of anaesthesia (General anaesthesia, any other segmental spinal anaesthesia).
- •2.Body Mass Index more than 35 3.Any major comorbid medical conditions,major end-organ dysfunction 4.Conditions that may interfere with patient ability to reciprocate study outcome.
结局指标
主要结局
Association of segmental spinal blockade to intraoperative materno-foetal outcome (cardiorespiratory and APGAR score) in parturient undergoing elective LSCS under spinal anesthesia at different block levels
时间窗: During intraoperative period
次要结局
- 1.Association of segmental spinal blockade to postoperative (24 hrs) materno-foetal outcome (cardiorespiratory) in parturient undergoing elective LSCS under spinal anesthesia at different block levels(2.Association of segmental spinal blockade to intraoperative Umbilical arterial blood gas parameters in parturient undergoing elective LSCS)
研究者
Dr Ruma Thakuria
All India Institute of Medical Sciences, Rishikesh
研究点 (1)
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