A Comparative Study Between Levobupivacaine 0.5% and Ropivacaine 0.75% in Patients Undergoing Spinal Anaesthesia for Lower Limb Orthopaedic Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of Analgesia
研究概览
简要总结
The purpose of this study is to compare the effects of two intrathecally administered drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia
详细描述
Bupivacaine is a highly cardiotoxic drug and also produces prolonged motor blockade.The newer drugs levobupivacaine and ropivacaine being comparatively less cardio and neurotoxic are preferred now a days.So, we conducted this prospective, randomized double blind study with an aim of comparing the efficacy and characteristics of these drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) class I & II patients of either sex
- •Age between 18-60 years
排除标准
- •Patient's refusal.
- •Patients who have contraindications to spinal anaesthesia / Local anaesthetic drugs.
- •Patients having h/o diabetes, neurological and musculoskeletal diseases.
研究组 & 干预措施
Levobupivacaine 0.5%
intrathecal administration of 15 mg of Levobupivacaine 0.5%
干预措施: Levobupivacaine (Drug)
Ropivacaine 0.75%
intrathecal administration of 22.5 mg of Ropivacaine 0.75%
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Duration of Analgesia
时间窗: 8 hours
Defined as time for first analgesic request by the patient
次要结局
- Duration of Motor Block(8 hours)
- Onset of Sensory Block at T10(30 minutes)
- Median Maximum Level of Sensory Blockade(8 hours)
- Time to Maximum Cephalic Spread of Sensory Block(8 hours)
- Onset of Motor Block to Bromage3(8 hours)
研究者
MANAZIR ATHAR
Doctor
Aligarh Muslim University