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临床试验/CTRI/2018/03/012402
CTRI/2018/03/012402已完成4 期

A comparative study of bupivacaine,ropivacaine and levobupivacaine in paediatric caudal block

Dr Jagdeep Sharma1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年4月20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
90
试验地点
1
主要终点
Caudal Effectiveness Score among the three groups was assessed.

研究概览

简要总结

There is limited data comparing all the three drugs. So, this study was performed to evaluate the caudal effectiveness of levobupivacaine, bupivacaine and ropivacaine in paediatric patients indergoing infra umbilical surgeries and associated complications with these drugs. This study also tried to find out difference in cardiac complications associated with these drugs.The diiference in mean caudal effectiveness score in all the three groups was statistically insignificant(p>0.05).21 patients in group I (Levobupivacaine), 19 patients in group II( Ropivacaine) and 22 patients in group III(Bupivacaine) had a caudal effectiveness score of 3. Mean postoperative pain scores as assessed with modified hanallah pain score were lower in bupivacaine group as compared to levobupivacaine and ropivacaine group during 1st hour post operatively. The duration of post operative analgesia in group I(levobupivacaine) was 126.15 mins, group II ropivacaine was 114.68 mins, and bupivacaine was 145.31 mins. The difference in duration of post operative analgesia was statistically highly significant.(p<0.001).Levobupivacaine and ropivacaine provided similar duration of post operative analgesia. Bupivacaine provided longer duration of analgesia than levobupivacaine and ropivacaine.

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
1.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • 90 patients of ASA grade I & II, undergoing infraumbilical surgery as circumscision, herniotomies, orchidopexies etc.

排除标准

  • Refusal by parents or guardian, pre existing neurological disease, hypersensitivity to local anaesthetics under study, bleeding diathesis or coagulation disorder, local sepsis at the site of puncture and technical problems such as persistent paresthesias or bloody/CSF tap.

结局指标

主要结局

Caudal Effectiveness Score among the three groups was assessed.

时间窗: The Caudal Effectiveness score was assessed after administration of anaesthesia before beginning of the surgery.

次要结局

  • Mean pain scores, duration of post operative analgesia and associated compplications with the use of the drugs.(. The duration of postoperative analgesia in group I (levobupivacaine) was 126.15±15.15mins (2.10±0.25hrs), group II (ropivacaine) was 114.68±11.32mins (1.91±0.18hrs), group III (bupivacaine) was 145.31±15.15mins (2.42±0.43hrs.)

研究者

发起方
Dr Jagdeep Sharma
申办方类型
Other [self]

研究点 (1)

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