A COMPARISION OF SPINAL ANAESTHESIA WITH HYPERBARICLEVOBUPIVACAINE 0.5%; ROPIVACAINE 0.75% WITHBUPIVACAINE 0.5% FOR ELECTIVE LSCS A PROSPECTIVERANDOMIZED DOUBLE BLIND STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The time to reach maximum sensory level of spinal anaesthesia
研究概览
简要总结
Hyperbaric bupivacaine is most common used drug in spinal anaesthesia. Levobupivacaine and ropivacaine are two amide local anaesthetic drugs developed in order to address the bupivacaine toxicity. This randomized prospective double-blind study will be conducted to compare the time to reach maximum sensory level, onset and duration of sensory & motor block, hemodynamic and adverse effects after SA with levobupivacaine and ropivacaine.
180 patients between 18 to 35 years, ASA grade II, weight 40-70 kg, BMI< 30 posted for elective LSCS under spinal anaesthesia will be randomly allocated using computer generated randomization list & sealed envelope technique into 3 groups with 60 patients in each group with allocation ratio 1:1:1. In Group L- inj Levobupivacaine 0.5 â„… (Heavy) 2cc, in Group R- inj Ropivacaine 0.75 â„… (Heavy) 2 cc & in Group B- inj Bupivacaine 0.5â„… (Heavy) 2 cc will be given for SA.
Time of onset of sensory Block, time of onset of motor Block, peak sensory level will be assessed by loss of pinprick sensation every 2 mins until the highest level is stabilized hemodynamic and adverse effects will be noted.
Data analysis will be done by appropriate statistical method with statistical software SPSS Ver. 20. P value less than 0.05 will be taken as significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Pregnant females undergoing elective LSCS surgery under spinal anaesthesia 2.ASA grade II 3.Age 18-35 years 4.Weight 40-70 kg 5.BMI< 30.
排除标准
- •1.Patient refusal for procedure.
- •2.History of allergy to drugs, Infection on back.
- •3.Patient with Uncontrolled hypotension, cardiovascular disease, hepatic or renal disease, bronchospastic disease.
- •4.ASA Grade 3 or more.
- •5.Emergency surgeries.
- •6.Patients taking any psychotropic drugs, Seizure disorder, Coagulopathy, morbid obesity or any contraindication to SA.
结局指标
主要结局
The time to reach maximum sensory level of spinal anaesthesia
时间窗: 2, 4, 6, 8, 10, 15, 20, 25, 30 minutes after spinal anaesthesia
次要结局
- The onset and duration of sensory & motor block Hemodynamic effects(Adverse effects)