Comparison of hyperbaric solutions of Bupivacaine, Levobupivacaine and Ropivacaine in Spinal anaesthesia for elective surgery: A prospective, Randomised, double-blind study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Onset and duration of sensory blockade with the three drugs
研究概览
简要总结
We are comparing bupivacaine with ropivacaine and levobupivacaine with the aim of studying clinical efficacy of hyperbaric bupivacaine, levobupivacaine and ropivacaine with respect to sensory and motor block characteristics, haemodynamic parameters and adverse effects.
Seventy five patients satisfying the inclusion and exclusion criteria undergoing elective lower limb and lower abdominal surgeries will be enrolled in our study after obtaining written informed consent. Patients will be randomly allocated into 3 groups of 25 each, receiving3 ml of 0.5% hyperbaric bupivacaine, levobupivacaine and ropivacaine.
All data will be compiled in a case record form. Data will be analysed using SPSS v21. Chi square test will be used as test of significance for categorical data and ANOVA test will be used as test of significance for continuous data (comparison of three groups means). Post hoc comparative analysis will be done to determine statistical significance among the three groups. P value less than 0.05 would considered as statistically significant.
The demographic data such as age, sex, height, weight and ASA grades, operative procedures and duration of surgery would be collected.
Parameters noted in case record form will be :
- Mean Time of onset of sensory block (T8)
- Mean Time to reach peak sensory block
- Maximal sensory level was assessed;
- Time for 2 segment regressions of sensory level
- The mean Duration of sensory blockade (Tanes)
- The mean Onset time of motor blockade
- The mean Duration of Motor Blockade
- Haemodynamic parameters like pulse rate, blood pressure, respiratory rate and saturation
- Mean arterial pressure
- The mean Time taken to Walk without support
- The mean Time taken to Void
- Perioperative adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA I and II.
排除标准
- •ASA III and IV Blood Dyscrasias Clotting disorders Pregnant and Lactating History of hypersensitivity disorders Pain modifying drugs.
结局指标
主要结局
Onset and duration of sensory blockade with the three drugs
时间窗: assessement done every minute till 5 minutes, every 5 minutes thereafter till end of procedure; post procedure assesment done evry 30 min till level recedes completely
次要结局
- 1.Onset & duration of motor blockade(2. Effect on heart rate)
研究者
Aishani Chawla
H.B.T.M.C and Dr R.N. Cooper hospital, Mumbai
