Comparative Evaluation of Newer Congeners i.e. Levobupivacaine and Ropivacaine With Bupivacaine, in Lumbar Epidural Anaesthesia for Hip Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Onset of sensory block
研究概览
简要总结
This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.
详细描述
Some of the most common day care surgeries are hip surgeries, in which local anaesthetic agents can be used via epidural route for both intra-op and post-op analgesia.
Among the drugs used nowadays are Lignocaine, Bupivacaine, Levobupivacaine and Ropivacaine.However Bupivacaine usage is not free from side effects.
The claimed benefits of both Levobupivacaine and Ropivacaine are reduced cardiac toxicity on overdose and more specific effects on sensory rather than motor nerve fibres.
Ropivacaine, an analog of Mepivacaine, is one of the long acting amide anaesthetic agent similar to Bupivacaine in chemical structure and anaesthetic function. It is a first enantiomer-specific compound, which has a reduced risk of cardio toxicity, neuro toxicity and rapid recovery of motor function. Levobupivacaine is the pure S (-)-enantiomer of Bupivacaine, and in recent year has emerged as a safer alternative for regional anaesthesia than its racemic parent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA Grade I and II patients of either sex
- •Age 18-60 years
- •Undergoing various hip surgeries under lumbar epidural anesthesia
排除标准
- •Refusal for epidural
- •ASA-III&IV
- •Head injury
- •Psychiatric disease
- •Known allergic to test drugs
- •Major systemic disease
- •Any analgesia with in past 24 hours
研究组 & 干预措施
Bupivacaine & Levobupivacaine
Bupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery
干预措施: Bupivacaine (Drug)
Bupivacaine & Levobupivacaine
Bupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery
干预措施: Levobupivacaine (Drug)
Bupivacaine & Ropivacaine
Bupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery
干预措施: Bupivacaine (Drug)
Bupivacaine & Ropivacaine
Bupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery
干预措施: Ropivacaine (Drug)
Ropivacaine & Levobupivacaine
Ropivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery
干预措施: Levobupivacaine (Drug)
Ropivacaine & Levobupivacaine
Ropivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Onset of sensory block
时间窗: 30 minutes
Time to achieve sensory block up to tenth thoracic dermatome
次要结局
- Time to achieve maximum motor block(45 minutes)
- Time for 2 segment regression of sensory block(90 minutes)
研究者
Dr Subhro Mitra
Assistant Professor
Government Medical College, Haldwani