跳至主要内容
临床试验/NCT04467463
NCT04467463Unknown不适用

Comparing Two Peripheral Nerve Block Techniques for Perioperative Analgesia During Cleft Palate Surgery in Pediatric Patients: Randomized Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
postoperative pain score

研究概览

简要总结

Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN) are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this study was to compare the analgesic effect as well as the incidence of complications associated with the use of bilateral GPN and bilateral SMN blocks in children undergoing palatoplasty surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

盲法说明

masking from the aim of the study

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •ASA I-III scheduled to undergo palatoplasty

排除标准

  • •bleeding disorders,
  • •skin lesions or wounds at site of proposed needle insertion,
  • •congenital heart disease,
  • •respiratory or
  • •cardiovascular disorders,
  • •children scheduled for combined procedures like palatoplasty with cheiloplasty or submucosal alveolar bone grafting,
  • •known hypersensitivity to local anesthetics or opioids and
  • •lack of parental consent.

研究组 & 干预措施

GPN

Experimental

administrated bilateral greater palatine nerve block using levobupivacaine 0.25%

干预措施: peripheral nerve block by 0.25% levobupivacaine (Procedure)

SMN

Experimental

administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%.

干预措施: peripheral nerve block by 0.25% levobupivacaine (Procedure)

结局指标

主要结局

postoperative pain score

时间窗: the first 12 postoperative hours

Pain assessment was done immediately postoperative using Objective behavioral pain score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Elsonbaty

Principal Investigator

Cairo University

研究点 (2)

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