Comparative Evaluation of Two Different Doses of 0.5 percent Hyperbaric Bupivacaine for Unilateral Spinal Anesthesia During Elective Inguinal Hernia Surgery
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To assess the level of sensory and motor block in operative side
研究概览
简要总结
This is a prospective and interventional randomized comparative study to compare sensory blockade on the operative side with two different doses of 0.5% hyperbaric bupivacaine for unilateral spinal anaesthesia during elective inguinal hernia surgery. Here the patient will be allocated to 2 groups by block randomization with sealed envelope system. One group will be given 7.5mg of 0.5% hyperbaric bupivacaine and the other group will be given 10mg of 0.5% hyperbaric bupivacaine. Level of sensory and motor block will be assessed in both operative and non operative side and non invasive haemodynamic variables (HR, SBP, DBP, MAP) will be observed from standard monitors intra operatively at 0 min, 5 min, 10 min, 20 min, 30 min, and at the end of surgery in both groups will be assessed. Time from end of spinal injection to achieve sensory block up to T10 and motor block score 3 by using modified bromage scale in both groups will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Physical Status Grade I & II, Patient to be operated for uncomplicated direct or indirect inguinal hernia under spinal anaesthesia.
- •BMI between 18 and 25.
排除标准
- •Patient with history of allergy to drugs, Abnormality or infection in lumbar and groin region, Patient having peripheral neuropathy and coagulation disorders.
结局指标
主要结局
To assess the level of sensory and motor block in operative side
时间窗: 0, 5, 10, 20, 30 minute, and at the end of surgery
次要结局
- To assess the level of sensory and motor block in both operative and nonoperative side(0, 5, 10, 20, 30 minute, and at the end of surgery)
- Non-invasive haemodynamic variables (Heart Rate, SBP, DBP, MAP)(0, 5, 10, 20, 30 minute, and at the end of surgery)
- Time from the end of spinal injection to achieve sensory block upto T10 & motor block score 3 using modified bromage scale in both groups(Recorded in minutes based on the time taken)