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临床试验/NCT02620566
NCT02620566已完成1 期

Evaluation of Anesthesia Profile in Pediatric Patients After Inguinal Hernia Repair With Caudal Block or Local Wound Infiltration

University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Time to First Analgesic Requirement

研究概览

简要总结

To our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (CB) or local wound infiltration (LWI).

详细描述

Total of 80 children aged 6 month to 7 years of ASA physical status I or II, undergoing unilateral hernia repair will be enroled in the study. One group will receive caudal block (CB) and the other group will receive local wound infiltration (LWI).

Group CB will receive 1ml kg 0,25% bupivacaine and group LWI will receive 0,2 ml kg 0,25% bupivacaine. Data taken will than be analyzed and interpreted. Postoperative pain will be assess using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10)(8) and the Faces Legs Activity Cry Consolability tool (FLACC, 0-10)(9) at 30 min and 1, 2, and 3 h after operation. The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. Twenty-four hours after surgery, reports of delayed side-effects and demands for rescue acetaminophen from the child will be gathered. The investigator, who will be blind to the treatment group, will document these data with the medical records.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Months 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 6 month to 7 years
  • ASA physical status I or II
  • undergoing unilateral hernia repair

排除标准

  • history of developmental delay or mental retardation
  • type I diabetes
  • known or suspected coagulopathy
  • known allergy to any local anesthetic
  • known congenital anomaly of the spine
  • signs of spinal anomaly or infection at the sacral or inguinal region

结局指标

主要结局

Time to First Analgesic Requirement

时间窗: 24 hours

The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. At t0. 30 min postoperative; t1 1h postoperative; t2 2h postoperative; t3 3h posoperative; t4 6h posoperative; t5 12h posoperative; t6 24h postoperative

次要结局

  • The total number of oral acetaminophen(The number of analgesic received for the period of 24 hours)

研究者

发起方
University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandra Gavrilovska-Brzanov MD Msc.

Principal Investigator

University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa

研究点 (2)

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