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临床试验/CTRI/2018/02/011711
CTRI/2018/02/011711已完成4 期

A randomised control trial comparing intrathecal ropivacaine, levobupivacaine and bupivacaine for caesarean section

ESICPostgraduate Institute of Medical Sciences and Research1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月2日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Duration of motor block

研究概览

简要总结

Aim of the study was to evaluate the spinal block characteristic of isobaric 0.5% levobupivacaine, isobaric 0.75% ropivacaine and its comparison with hyperbaric 0.5% bupivacaine for elective caesarean section.  100 term pregnant women with singleton pregnancy scheduled for elective caesarean section will be enrolled in this prospective double blind randomised trial. Written informed consent  will be  taken from all patients.   Subarachnoid block will be given  for caesarean section with 25 g spinal needle in L3-L4 with patients in left lateral position After confirming free flow of CSF, 2ml of test drug will be injected intrathecally.

Group B = 2 ml of  0.5% hyperbaric bupivacaine

Group R = 2 ml  or 0.75 % isobaric ropivacaine

Group LB = 2 ml of 0.5 % isobaric levobupicaine

The following variables will be measured during intraoperatively:  Sensory block and block onset times: modified bromage scale, Maximum sensory and motor block level achieved,   Maternal Hemodynamic parameters ( 5 min interval),  Neonatal Apgar Scores ( 1 and 5 mins), Quality of Anaesthesia  (at the end of surgery), Quality of muscle relaxation, Sensory and motor block regression times,  First analgesic request time, Side effects if any.  Patients will be followed up on post-operative days 1 and 3  for any headache, backache, tingling or numbness in lower limbs.

研究设计

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

  • Full term patients scheduled for caesarean section of ASA status1 and 2, age group of 18 to 40 years, body weight of 45 to 85 kg and height of 145 to165cm.

排除标准

  • Parturients with hypersensitivity to local anesthetics, contraindications to neuraxial block, twin pregnancy, obstetric complications or fetal compromise were excluded.

结局指标

主要结局

Duration of motor block

时间窗: Duration of motor block

次要结局

  • Sensory and Motor block onset times(Sensory and Motor block regression times)

研究者

发起方
ESICPostgraduate Institute of Medical Sciences and Research
申办方类型
Research institution and hospital

研究点 (1)

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