Evaluation of Anesthesia Profile in Pediatric Patients After Inguinal Hernia Repair With Caudal Block or Local Wound Infiltration
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
- 否
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
Aleksandra Gavrilovska-Brzanov MD Msc.
Principal Investigator
University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
