Comparison of Ropivacaine and Ropivacaine with Dexmedetomidine in ultrasound guided supraclavicular brachial plexus block for upper limb surgeries- a double blinded, randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dexmedetomidine added to Ropivacaine prolongs the duration of analgesia, in hastening and prolonging sensory and motor block when compared to Ropivacaine alone in supraclavicular brachial plexus block for upper limb surgeries
研究概览
简要总结
This is a double blinded randomized controlled trial to assess the efficacy of Dexmedetomidine as an adjuvant to Ropivacaine in ultrasound guided brachial plexus block for upper limb surgeries. Sample size was calculated by n- master software versiov 2.0. With power of 80% and alpha error of 5%, the sample size required is 30 in each group. To account for drop outs, the sample size was taken as 35 in each group. Randomisation was done by computer generated permuted block randomisation. Control group C (n= 35) will receive 29 ml 0.75% Ropivacaine+ 1 ml normal saline and study group D (n=35) will receive 29 ml 0.75% Ropivacaine+ Dexmedetomidine 50mcg( 0.5ml)+0.5 ml normal saline, to a total volume of30 ml in each group. Parameters assessed- onset of sensory block,duration of sensory block, onset of motor block, duration of motor block, duration of analgesia,hemodynamic parameters, sedation and adverse effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status 1 and 2, of either gender between 18 and 70 years of age for upper limb surgeries below mid humerus.
排除标准
- •morbid obesity, coagulopathy, uncontrolled diabetes mellitus, peripheral vascular disease, neurological disease, known allergy to local anaesthetics.
结局指标
主要结局
Dexmedetomidine added to Ropivacaine prolongs the duration of analgesia, in hastening and prolonging sensory and motor block when compared to Ropivacaine alone in supraclavicular brachial plexus block for upper limb surgeries
时间窗: Hemodynamic parameters,sensory and motor block, analgesia are assessed at 5, 10, 15, 20, 25, and 30 min and thereafter every 15 min for 1 hour till the block effect has resolved
次要结局
- Dexmedetomidine added to Ropivacaine is safer when compared to Ropivacaine alone in supraclavicular brachialplexus block for upper limb surgeries(Adverse effects are assessed at 5, 10, 15, 20, 25, and 30 min and thereafter every 15 min for 1 hour till the block effect has resolved)