Prospective Randomised Comparative Study of Intrathecal Levobupivacaine and Levobupivacaine with Fentanyl in Infraumbilical Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary objectives is to compare the onset and duration of sensory and motor block in subarachinoid block given with levobupivacaine versus levobupivacaine with fentanyl
研究概览
简要总结
Spinal anaesthesia is themost commonly used technique for infraumbilical surgeries because of itsunmatchable reliability, cost effectiveness, effective analgesia, musclerelaxation and prolonged postoperative analgesia.. Levobupivacaine has beenwidely used in ambulatory surgeries after the development of low dose spinalanaesthesia technique. To improve the block characteristics of intrathecallyadministered low dose local anaesthetics, addition of adjuvant is must. Intrathecalopioids enhance sensory block without prolonging motor and sympathetic block.Among them, Fentanyl has rapid onset of action, binds strongly to plasmaproteins and potentiates the afferent sensory blockade thus facilitatesreduction in the dose of local anesthetics.The aimof the present study is to evaluate the safety and efficacy of equal doses oflevobupivacaine plain and levobupivacaine plus fentanyl with respect to onset and duration of sensoryand motor block, postoperative analgesia, hemodynamic parameters and sideeffects and complications in spinal anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All patient giving consent undergoing infraumbilical surgeries ASA grade I,II.
排除标准
- •Patients known or suspected to have allergy for study drug.
- •Patients with any infection at the site of injection Pregnant patients.
结局指标
主要结局
The primary objectives is to compare the onset and duration of sensory and motor block in subarachinoid block given with levobupivacaine versus levobupivacaine with fentanyl
时间窗: baseline , after intrathecal administration of drug at 2 mins , 4 mins, 6mins,8mins,10mins,12mins,14mins,16mins,18mins,20mins and 30mins
次要结局
- Hemodynamic changes between two groups including hear rate , blood pressure and mean arterial pressure(baseline , after induction at 2 mins , 4 mins, 6mins,8mins,10mins,12mins,14mins,16mins,18mins,20mins and 30mins)