A Comparative Evaluation of Hyperbaric Ropivacaine with Fentanyl and Hyperbaric Levobupivicaine with Fentanyl for Inguinal Hernia Surgeries under Spinal Anaesthesia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare onset and duration of sensory and motor blockade
研究概览
简要总结
Levobupivacaine, an amide local anesthetic is an S-enantiomers of bupivacaine. It has equivalent clinical effi cacy to bupivacaine and less cardiotoxic. Ropivacaine is similar in chemical structure to bupivacaine, but it is 30-40% less potent. It has shorter duration of action than bupivacine. Intrathecal opioids synergistic with local anaesthetics and intensify the sensor block and hastening recovery times.The aim of the study is to compare the onset, duration of sensory block and motor block, postoperative analgesia and haemodynamic changes occurring with 0.75% hyperbaric ropivacaine with fentanyl and 0.5% hyperbaric levobupivacaine with fentanyl when given intrathecally.A Prospective randomized double blind study will be conducted in 60 patients undergoing inguinal hernia surgeries will be divided in two groups. Group LF (n = 30): 2.5 ml of 0.5% levobupivacaine (hyperbaric) + 0.5 ml fentanyl(25µg) group RF (n = 30): 2.5 ml of 0.75% ropivacaine (hyperbaric) + 0.5 ml fentanyl(25µg).
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 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •ASA 1 and 2 Age between 18 to 65 years Patients undergoing unilateral inguinal hernia.
排除标准
- •Coagulation disorders Local site infection Neurological disorders Psychiatric disorders Patient refusal Hypersensitivity to drugs used in the study.
结局指标
主要结局
To compare onset and duration of sensory and motor blockade
时间窗: 2 min | 3 min | 6 min | 10 min | 15 min | 30 min | 45 min | 60 min | 2 hr | 3 hr | 6 hr
次要结局
- To monitor hemodynamic parameters and observe adverse effects(2 m8n)
研究者
Dr Sujani Gooty
Government Medical College