Ultrasound Guided Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block for Postoperative Analgesia in Children Undergoing Inguinal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative CHEOPS scale
研究概览
简要总结
Investigators aim to compare the efficacy of US-guided II/IH nerve block versus US-guided ES block for pediatric unilateral inguinal hernia repair with respect to postoperative analgesia
详细描述
regarding patient registry; a prior G power analysis was done. 24 per group was determined to achieve 80% power to detect a difference of 60 min in time to first rescue analgesia between the two groups with a significance level (α) of 0.05 using a two-sided two-sample t-test; 25 patients were included per group to replace any dropouts.
- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by the Shapiro test. Data will be presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. For pain score, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •: American Society of Anesthesiologists physical status I - II
排除标准
- •History of clinically significant cardiac disease.
- •History of clinically significant hepatic disease.
- •History of clinically significant renal disease.
- •History of clinically significant neurological disease.
- •Known allergy to local anaesthetics
研究组 & 干预措施
Ilioinguinal/iliohypogastric nerve blocks
The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks
干预措施: Ilioinguinal/iliohypogastric nerve blocks (Procedure)
Erector spinae nerve block
The patient will receive ultrasound-guided erector spinae nerve block
干预措施: Erector spinae nerve block (Procedure)
结局指标
主要结局
Postoperative CHEOPS scale
时间窗: for 6 hours after surgery
The scale includes six entries with an appropriate point evaluation focused on the character of crying (1-3 points), facial expressions (0-2 points), verbal reaction (0-2 points), position of the body (1-2 points), touch (1-2 points), and position of the legs (1-2 points). Minimum score is 4 (no pain) and maximum is 13 (maximum pain). Grades are summed together. CHEOPS has a minimum possible score of 4 points (no pain) to a maximum of 13 points (the worst pain). When the postoperative pain score exceeded four, rescue analgesia was given with a 20mg/kg paracetamol suppository.
次要结局
- incidence of postoperative nausea and vomiting(during first 24 hours)
- number of patients requiring rescue analgesic(during first 24 hours)
- Time to first analgesic request(during first 24 hours)