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临床试验/CTRI/2022/04/042328
CTRI/2022/04/042328尚未招募不适用

Comparison of spinal block characteristicsbetween height and weight based dosage versus fixed dosage of intrathecal bupivacaine for elective caesarean section

Saveetha medical college hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月7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
100
试验地点
1
主要终点
comparison of heart rate and blood pressure between the fixed dose of bupivacaine and bupivacaine based on Hartens chart

研究概览

简要总结

The preferred choice of anaesthesia for conducting emergency and elective caesarean section is spinal considering the various physiological changes in pregnancy. Hypotension still persists as a major problem during spinal anaesthesia.

Various strategies employed to prevent hypotension are preloading with intravenous fluid, leg elevation, prophylactic administration of vasopressors, using lower dose of local anaesthetic agents, use of additives like clonidine, opioids etc.

The dose of bupivacaine is reduced in obstetric patients due to increased sensitivity of neural tissue, alteration in CSF volume, weight gain and exaggerated lordosis. As a result of these factors which ultimately result in significant cephalad spread resulting in higher level of blockade causing maternal discomfort and hypotension.

The dose of bupivacaine for patients undergoing LSCS under spinal is around 12mg (12.78 mg for normal weight and 11.86 mg for obese population). Studies have proved that dose of bupivacaine based on height for spinal anaesthesia in LSCS patients is 0.06mg/cm.

The use of 8-10mg bupivacaine has been associated with lesser incidences of hypotension but greater intraoperative need for analgesia to dampen the pain.

This results in a wide range of dose of bupivacaine administered to these patients.

The purpose of this study is to analyze the characteristics of block achieved with height and weight adjusted dose of bupivacaine with fentanyl versus a fixed dosage of bupivacaine with fentanyl in elective caesarean section patients so as to find the optimum dose of drug required for adequate anaesthesia, which in turn will reduce the usage of vasopressors.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator 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

  • Patient undergoing elective LSCS 2) Age 18-40 yrs 3) ASA II patients 4) Weight 50-90 kg 5) Height 140cm-180cm 6) Singleton pregnancy.

排除标准

  • Emergency caesarean section 2) Patients refusing spinal anesthesia 3) Infection at the site of regional blockade 4) Bleeding diathesis 5) Hypersensitivity to the study drug 6) Allergy to local anaesthetics 7) Neurological diseases 8) Spinal deformities.

结局指标

主要结局

comparison of heart rate and blood pressure between the fixed dose of bupivacaine and bupivacaine based on Hartens chart

时间窗: Baseline, pre-spinal, post-spinal, 5mins, 15mins, 30mins, 60 mins, 120 mins, post anesthesia care unit

次要结局

  • Comparison of onset of sensory blockade in both the groups
  • comparison of motor regression time(every 15 minutes)
  • comparison of sensory regression(every 15 minutes)
  • quality of block assessed by surgeon(after surgery)
  • quality of Intraoperative analgesia assessed by patient(once after surgery)
  • APGAR score of baby(after baby delivery and at 5 minutes after delivery)
  • complications(every 10 minutes)

研究者

发起方
Saveetha medical college hospital
申办方类型
Private medical college

研究点 (1)

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