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临床试验/NCT04668183
NCT04668183已完成不适用

Ultrasound-guided Pudendal Nerve Block Versus Ultrasound-guided Dorsal Penile Nerve Block for Pediatric Distal Hypospadias Surgery

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Time of Postoperative analgesic requirement

研究概览

简要总结

Hypospadias repair is a urological surgical operation that is very painful in the postoperative period and requires long-term analgesia. A dorsal penial nerve block (DPNB) and pudendal nerve block (PNB), which are regional anesthesia techniques for this operation, are used to provide postoperative analgesia.

详细描述

The regional anesthesia techniques used for postoperative analgesia in hypospadias repair include the peripheral nerve blocks of pudendal nerve block (PNB) and dorsal penile nerve block (DPNB). Ultrasound (US) has recently become increasingly popular in regional anesthesia practice and is used to aid these two peripheral nerve block applications in various pediatric urological procedures. US-guided DPNB has been shown to provide effective and long-term analgesia when compared to caudal epidural block in a recent study on hypospadias surgery in the pediatric population.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Male patients aged between 1-7 years
  • American Society of Anesthesiologists (ASA) I-II group
  • Distal hypospadias surgery
  • Able to communicate in Turkish
  • Willing to participate to the study (parents and children)

排除标准

  • Less than 1 or more than 7 years of age
  • A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital low back anomaly, liver disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
  • Unwilling to to participate to the study ((parents or children)

结局指标

主要结局

Time of Postoperative analgesic requirement

时间窗: Up to 24 hours

It was assessed six times after the operation with Children's Hospital Eastern Ontario Pain Scale. The lowest scale score is 4 points and the highest 13 points. Significant pain behavior for Children's Hospital Eastern Ontario Pain Scale has been identified as 7 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse. Paracetamol was administered IV at a dose of 10 mg/kg if the scale score was 7 or higher.

次要结局

  • Rate of Postoperative complications(Up to 24 hours)
  • Level of Postoperative pain(Up to 24 hours])
  • Level of Parent satisfaction(Up to 24 hours)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Volkan Ozen

MD

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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