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临床试验/NCT04268511
NCT04268511已完成不适用

Ultrasound-Guided Low-dose Caudal Epidural Block Versus Ultrasound-Guided Pudendal Nerve Block for Pediatric Circumcision: A Prospective Observational Study

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8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
100
试验地点
1
主要终点
Time of Postoperative analgesic requirement

研究概览

简要总结

The regional anesthesia methods of caudal epidural block (CEB) and dorsal penile nerve block (DPNB) play an important role in providing postoperative pain control in pediatric circumcision surgery. However, the short-term postoperative analgesic effect and the risk of block failure limit the use of DPNB, a peripheral nerve block.

详细描述

CEB is a neuraxial block and commonly used to control moderate and severe postoperative pain following surgery related to the lumbosacral and midthoracic dermatomes. CEB can have serious undesirable complications such as intravascular and subarachnoid injection, urinary retention and motor block. Pudendal nerve block can be used as an alternative to both DPNB and CEB for penile surgery such as circumcision. The pudendal nerve is a peripheral nerve combining the anterior rami of the sacral plexus nerves (S2-S4) and provides motor and sensory innervation to the perineal region.

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
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Male patients aged between 4-12 years
  • ASA (American Society of Anesthesiologists) I-II group
  • Scheduled for circumcision
  • Able to communicate in Turkish
  • Willing to participate to the study (parents and children)

排除标准

  • Patients aged less than 4 or more than 12 years
  • Neurological deficit
  • Bleeding diathesis
  • History of local anesthetic allergy
  • Current infection or redness in the region to be injected
  • Congenital lower back anomaly
  • Liver disease
  • Psychiatric disorder
  • Mental retardation
  • Communication problem
  • Refusal to participate in the study.

结局指标

主要结局

Time of Postoperative analgesic requirement

时间窗: Up to 12 hours

It was assessed five 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 30 minutes, 1st, 2nd, 6th, and 12th hour pain levels were evaluated by the ward nurse.

Level of Postoperative pain

时间窗: At the 24th hour

It was assessed one time for 24th hour by parents with Faces Pain Scale-Revised. The scale is scored in even numbers from 0 to 10, which themselves indicate no pain and significant pain, respectively. The parents were also informed that a scale score of 4 or more

次要结局

  • Rate of Postoperative complications(Up to 12 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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