跳至主要内容
临床试验/CTRI/2024/03/063448
CTRI/2024/03/063448尚未招募Phase 3 4

A comparative study of transversus abdominis plane block versus caudal epidural block for postoperative analgesia in children undergoing elective infra umbilical surgeries

Guru Gobind Singh Medical College Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
Phase 3 4
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 the time of first rescue analgesia from the time of caudal and TAP block

研究概览

简要总结

Introduction : Lower abdominal surgeries are commonly performed in pediatric surgical units {for eg., Inguinal herniotomy, appendectomy, urethroplasty etc.,} and thesre are more commonly associated with post operative pain and discomfort. For effective pain control,Various analgesic modalities have been tried including low dose opioids, NSAIDs, local wound infiltration, neuraxial anesthesia and peripheral nerve blocks like ilioinguinal, iliohypogastric and Transversus abdominis plane block.

Aim and objectives : To compare the post operative analgesic efficacy of Transversus Abdominis Plane block versus Caudal block in pediatric patients undergoing infra umbilical surgeries.

The study will be conducted in a prospective, comparative and randomized manner in GGS medical college hospital, Faridkot on 60 children belonging to ASA grade I & II aged 2 to 8 years scheduled for infra umbilical surgeries under general anesthesia. The patients will be randomly allocated into two groups,

Group T : will receive 1ml/kg of 0.25% levobupivacaine in USG guided TAP block.

Group C: will receive 1ml/kg of 0.25% levobupivacaine in Caudal block .

The patients will be observed post operatively for duration till first rescue analgesic requirement, total rescue analgesic consumption, pain score using FLACC pain score and any side effects and outcomes will be analyzed

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • 1.Pediatric patients aged 2 to 8 years belonging to ASA Grade I and II 2.Elective infra umbilical surgeries.

排除标准

  • 1.children undergoing bilateral infra umbilical surgeries.
  • 2.children with altered sacral,caudal anatomy and skeletal deformities.
  • Local infection at the site of block 4.children with renal or hepatic insufficiency 5.known allergy to study drugs.

结局指标

主要结局

To compare the time of first rescue analgesia from the time of caudal and TAP block

时间窗: Outcome will be assessed at the end of one and half year of study

次要结局

  • FLACC Scale score and intra operative hemodynamic variables(Outcome will be assessed at the end of one and half year of study)

研究者

发起方
Guru Gobind Singh Medical College Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Vigneshwaran V

Guru Gobind Singh Medical College Hospital

研究点 (1)

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