Comparative study of 0.5 percentage hyperbaric levobupivacaine, 0.75 percentage hyperbaric ropivacaine and 0.5 percentage hyperbaric bupivacaine with fentanyl in subarachnoid block for lower limb surgeries.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Onset of sensory and motor block
研究概览
简要总结
Bupivacaine is the most commonly used intrathecal local anaesthetic ,but due to CNS and CVS toxicity associated with it lead to research of better alternatives for spinal anaesthesia. Studies have reported that hyperbaric 0.5% ropivacaine produce reliable subarachnoid block but of shorter duration than 0.5 % hyperbaric bupivacaine and 0.5 % hyperbaric levobupivacaine.A prospective randomized double blind study is planned to be conducted on 195 adult ASA grade I, II, III patients posted for lower limb surgeries under spinal anaesthesia after taking a written informed consent. Enrolled patients will be randomly divided into three equal groups to receive either 2.5ml of 0.5% hyperbaric levobupivacaine with , 2.5ml of 0.75% hyperbaric ropivacaine and 2.5ml of 0.5% hyperbaric bupivacaine with 25µg fentanyl (total volume-3ml) in subarachnoid block. Patient will be observed for duration of sensory block, time of onset of sensory and motor block, maximum sensory level, time to achieve maximum sensory level, time to complete motor block, time required for complete motor regression, duration of analgesia and hemodynamic parameters. This study will help us to compare 0.5% hyperbaric levobupivacaine, 0.75% hyperbaric ropivacaine and 0.5% hyperbaric bupivacaine in combination with fentanyl in terms of clinical efficacy and safety profile for use in lower limb surgeries under subarachnoid block
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •American Society of Anaesthesiologists (ASA) gradeI, II and III.
排除标准
- •Patient refusal for subarachnoid block.
- •Patients with allergy to local anaesthetic drugs or any history of anaphylacticreaction to the drugs used.
- •Patients with coagulopathy evidenced by history and laboratory investigations.
- •Patients with infection at injection site
- •Patients with spinal deformities like kyphoscoliosis and scoliosis etc.
- •Patients with history of pre-existing neurological disease.
- •Unable to comprehend sensory and motor block.
- •Patient’s refusal for consent.
- •Patients with failed spinal anaesthesia and subsequent conversion to general anaesthesia.
结局指标
主要结局
Onset of sensory and motor block
时间窗: 0 min, 2min, 4min, 6min, 8min , 10min ,15min and thereafter every 15min till two dermatome regression from maximum level of sensory block occurs
次要结局
- 1.To determine highest level and duration of sensory block.(2. Duration of motor block)
研究者
Dr M Rupinder Singh
Dayanand Medical College and Hospital
