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临床试验/CTRI/2022/07/043668
CTRI/2022/07/043668
尚未招募
2/3 期

COMPARISON OF ANALGESIC EFFICACY OF CAUDAL BLOCK WITH OR WITHOUT USING ULTRASOUND TECHNIQUE IN CHILDREN UNDERGOING INFRAUMBILICAL SURGERIES

SGRDIMSAR1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2022年4月7日最近更新:

概览

阶段
2/3 期
状态
尚未招募
发起方
SGRDIMSAR
入组人数
105
试验地点
1
主要终点
To compare the analgesic efficacy of caudal block with or without using ultrasound technique in children undergoing infraumbilical surgeries

概览

简要总结

Caudal block is a popular and reliable technique in pediatric surgeries. Ultrasound guided caudal block is known to improve the success rate and reduce the complications noted with the landmark technique. We aimed to conduct a study to evaluate analgesic efficacy of caudal block in pediatric patients with or without ultrasound technique as primary outcome in infra umbilical surgeries. Patients will be randomly allocated according to 105 computer generated coded slips and sealed in an envelope and divided into three groups of 35 patients each.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
1.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I, II Children undergoing infra umbilical surgeries.

排除标准

  • 1.Children with pre-existing neurological disease 2.Children with known hypersensitivity to local anaesthetic agents.
  • 3.Children suffering from bleeding diathesis or coagulation disorders.
  • 4.Local sepsis at the site of proposed puncture.
  • 5.Sacral deformity or tuberculosis of spine.
  • 6.Children being treated with anticoagulants, CNS active drugs.
  • 7.Technical problems (persistent parasthesias, persistent bloody tap).

结局指标

主要结局

To compare the analgesic efficacy of caudal block with or without using ultrasound technique in children undergoing infraumbilical surgeries

时间窗: from the start of anaesthesia till 24 hours postoperatively.

1.To evaluate analgesic efficacy of caudal block in terms of –

时间窗: from the start of anaesthesia till 24 hours postoperatively.

a.Caudal effective score

时间窗: from the start of anaesthesia till 24 hours postoperatively.

b.Hemodynamic stability

时间窗: from the start of anaesthesia till 24 hours postoperatively.

c.Recovery profile

时间窗: from the start of anaesthesia till 24 hours postoperatively.

2.To study the complications of procedure and side effects of drug.

时间窗: from the start of anaesthesia till 24 hours postoperatively.

次要结局

  • To compare the analgesic efficacy of caudal block with Bupivacaine alone or with dexamethasone using ultrasound technique in children undergoing infraumbilical surgeries

研究者

发起方
SGRDIMSAR
申办方类型
Research institution and hospital

研究点 (1)

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