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临床试验/CTRI/2022/12/048187
CTRI/2022/12/048187尚未招募不适用

COMPARISION OF ULTRASOUND GUIDED PUDENDAL NERVE BLOCK AND CAUDAL EPIDURAL BLOCK FOR POST OPERATIVE ANALGESIA IN CHILDREN UNDERGOING HYPOSPADIAS REPAIR.

Maulana Azad Medical College and Associated Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年12月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Percentage of patients requiring analgesia during the first 24 hours after surgery

研究概览

简要总结

Regional anaesthetic techniques are frequently used with general anaesthesia to manage intra and post-operative pain, reduce parenteral opioid requirement, and facilitate pain control during paediatric procedures. One of the most often used regional anaesthesia techniques in children is caudal epidural block (CEB). However, single injection CEB has a short duration of action and anatomical variations, and abnormalities may make administration of CEB challenging. Recently, peripheral nerve blocks are increasingly being employed for peri-operative analgesia when appropriate, as they have less risk of side effects as combined with neuraxial procedures. Also, the availability of ultrasound machines has made this easier and safer. Pudendal nerve block (PNB) is a peripheral nerve block that is frequently used to provide efficient pain control after penile surgery. A few previous studies have shown that PNB is effective for providing prolonged post operative analgesia.1,2 PNB can be accomplished utilising a landmark technique with transcutaneous use of a peripheral nerve stimulator or by ultrasonographic guidance (USG).2 Naja ZM et al compared effectiveness of PNB with CEB and found that the percentage of patients who received analgesics during the first 24 hours after hypospadias surgery was significantly higher in the CEB (70%) compared with the nerve stimulator guided PNB group (20%, p < 0.0001) and analgesic consumption was also higher in the CEB group.1 We decided to compare USG guided PNB with CEB for post operative analgesia in children undergoing hypospadias surgery.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
2.00 Year(s) 至 12.00 Year(s)(—)
性别
Male

入选标准

  • Physical status ASA I-II.
  • Age of patient 2-12 years
  • Anticipated duration of surgery: 1-2 hour.

排除标准

  • H/O growth retardation or mental disorder affecting pain score assessment
  • Patient or parent refusal for the block
  • Patients with bleeding and coagulation disorder
  • Patients with vertebral column abnormalities or any neurological disorders
  • Infection at injection site.

结局指标

主要结局

Percentage of patients requiring analgesia during the first 24 hours after surgery

时间窗: 12 MONTH

次要结局

  • • Pain scores (Modified Objective Pain Score)(• Postoperative analgesic consumption)

研究者

发起方
Maulana Azad Medical College and Associated Hospital
申办方类型
Government medical college

研究点 (1)

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