Effect of intravenous dexmedetomidine infusion on femoro-sciatic nerve block in below knee surgeries: a randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- to access the Motor and Sensory Block characteristics
研究概览
简要总结
This study will be a randomized double blinded, prospective, comparative study, to be carried out in 52 patients of ASA I and II undergoing below knee surgery with combined femoral and sciatic nerve block (popliteal-sciatic approach).
The patients will be randomly divided into two groups of 26 each. Group B (n=26) will receive inj. 0.375% Ropivacaine (40ml) with 20ml of intravenous infusion of dexmedetomidine over 10minuets. Group A (n=30) will receive inj. 0.375% Ropivacaine (40ml) with intravenous infusion 20ml of Normal Saline over 10 minuets.
The onset and duration of sensory block and motor block, duration of analgesia or time to first rescue analgesic request (TFAR) and side effects will be assessed and recorded.
All the findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analysed and inference drawn to evaluate and compare the two groups on sensory and motor block onset and duration .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Patients of age group 18 to 60 years.
- •Patients of American Society of Anaesthesiologists (ASA) physical grade I or II.
排除标准
- •Hypersensitivity to the amide group of local anaesthetic agents and dexmedetomidine.
- •Patients having hypertension/diabetes mellitus / neuropathy / peripheral nerve injury
- •Pregnancy and lactation
- •Patient on anticoagulants or bleeding disorder
- •Patients having problems in communication
- •Infection at the site of drug injection.
结局指标
主要结局
to access the Motor and Sensory Block characteristics
时间窗: Outcome will be assessed from the point of | administration of femoro-sciatic nerve block till 24hrs after the surgery. Data will be then | assessed at the end of two years.
次要结局
未报告次要终点
研究者
GOKULNATH THANGARAJ
Regional Institute of Medical Sciences, Imphal, Manipur