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