Intrathecal hyperbaric bupivacaine versus hyperbaric ropivacaine in spinal anaesthesia in caesarean sections: a randomised control trial in a teaching hospital in northeast India.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Neon
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To compare the onset of action, duration of sensory and motor block, and duration of effective analgesia induced by intrathecal hyperbaric ropivacaine and hyperbaric bupivacaine in patients undergoing elective caesarean section.
研究概览
简要总结
Group B of inj bupivacaine 0.5% hyperbaric solution 2.4 cc will be compared with Group R inj ropivacaine 0.75% 2.4 cc hyperbaric solution.
Each group 33 each elective caesarean cases will be taken as per inclusion and exclusion criteria.
The injection will be given using 25G quinckes spinal needle at L3-4, L4-5 level, sub arachnoid space in sitting position.
Onset of sensory, motor blockade, duration regression of sensory (T10)and motor (bromage 0), time of use of rescue analgesia,
Intra op nd post op complicationa like nausea, vomiting, bradycardia, hypotension, respiratory depression shivering to be compared
Haemodynamics intra op and post op till 12 hours
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •i.All patients who will be registered for elective caesarean delivery and belonging to ASA (American Society of Anesthesiologists) grade I & II only.
- •ii.Patients between 145to 165 cms of height.
- •iii.Patients who will give valid informed written consent.
- •iv.Pregnancy over 37 weeks and less than 42 weeks.
- •v.Patient with weight of 45-95kgs.
排除标准
- •i.Patient with abnormalities and problems in the embryo.
- •ii.Patient with indication of an emergency caesarean section.
- •iii.Patients having history of hypersensitivity to anesthetic agents.
- •iv.Infection at the subarachnoid block injection site.
- •v.Pre-term and post term delivery.
- •vi.ASA class higher than II.
结局指标
主要结局
To compare the onset of action, duration of sensory and motor block, and duration of effective analgesia induced by intrathecal hyperbaric ropivacaine and hyperbaric bupivacaine in patients undergoing elective caesarean section.
时间窗: 0,3,6,9,12,15,20,30,45,60,90,120,150,180,240,300,360,480,600,720 hours
次要结局
- 1.To compare the haemodynamic variables in two groups during the intra operative & post operative period for 12 hours.(2.To evaluate & compare the adverse effects intra-operatively & post-operatively in the two groups.)