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临床试验/CTRI/2018/05/014012
CTRI/2018/05/014012已完成4 期

A Comparative Study Of Equipotent Doses Of Intrathecal Levobupivacaine With Fentanyl And Ropivacaine With Fentanyl For Lower Abdominal And Lower Extremity Surgery

St Stephens hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年1月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Levobupivacaine + Fentanyl group-

研究概览

简要总结

We conducted a randomized Comparative study in 60 ASA 1 patients undergoing lower Abdominal  or lower Extremity surgery, divided into 2 groups 30 of each, LF and RF. Group LF was given Intrathecal Levobupivacaine 15mg+ Fentanyl 25mcg. Group RF was given Intrathecal Ropivacaine 22.5mg+ Fentanyl 25mcg. We compared the onset and duration of sensory block as well as motor block, duration of analgesia, hemodynamic stability and side effects. We found that Levobupivacaine had faster onset as well as longer duration of both sensory and motor block and longer duration of analgesia also with comparable hemodynamics. So we recommend the use of Intrathecal Levobupivacaine combined with Fentanyl for lower Abdominal And Lower Extremity surgeries.

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
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA CLASS 1 OR 2 Duration of surgery < 120minutes Body weight 30 to 80 kg.

排除标准

  • ASA CLASS 3 OR 4 Emergency surgery Pregnancy Contraindications to subarachnoid block.

结局指标

主要结局

Levobupivacaine + Fentanyl group-

时间窗: For Onset 30min | For Duration 360min

Onset of sensory block was 2.9 min

时间窗: For Onset 30min | For Duration 360min

Onset of motor block was 3mins

时间窗: For Onset 30min | For Duration 360min

Duration of sensory block was 271.5 mins

时间窗: For Onset 30min | For Duration 360min

Duration of motor block was 252.1 mins

时间窗: For Onset 30min | For Duration 360min

Ropivacaine + Fentanyl group-

时间窗: For Onset 30min | For Duration 360min

Onset of sensory block was 3.9mins

时间窗: For Onset 30min | For Duration 360min

Onset of motor block was 5mins

时间窗: For Onset 30min | For Duration 360min

Duration of sensory block was 228 mins

时间窗: For Onset 30min | For Duration 360min

Duration of motor block was 195.3 mins

时间窗: For Onset 30min | For Duration 360min

次要结局

  • Duration of analgesia-(Levobupivacaine group 292.8mins)

研究者

发起方
St Stephens hospital
申办方类型
Private hospital/clinic

研究点 (1)

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