Post operative analgesic efficacy of ultrasound guided caudal epidural block compared to retrolaminar block for elective unilateral open inguinal hernia repair in children: a randomized double blind controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the post-operative analgesic efficacy between Caudal epidural block and Retrolaminar block in children undergoing elective unilateral open inguinal hernia repair
研究概览
简要总结
This study is a randomized double controlled trial, comparing the analgesic efficacy of ultrasound guided caudal epidural block with retrolaminar block using bupivcaine.The primary aim of this study, is to compare the postoperative analgesic efficacy of both the blocks,by using duration of post-operative analgesia and time to firstrescue analgesic requirement. Secondary outcome includes, number of patientsrequiring rescue analgesia, total analgesic consumption in the first 24h postoperatively, adverse events and parental and surgeon satisfaction score.Fifty children undergoing elective unilateral open inguinal hernia repair willbe enrolled in the study
Post-operative pain will be assessed with FLACCscore and rescue analgesia will be given if FLACC score is more than three.Time to firstrescue analgesic requirement, number of rescue analgesics in 24 hour period, parentaland surgeon satisfaction,post-operative adverse events such as nausea, vomiting, hypotension,urinary retention will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All the patients scheduled for for elective unilateral open inguinal hernia repair under general anaesthesia.
- •2.ASA physical status I and II 3.Age 2-6 years.
排除标准
- •1.Patients with known allergies to local anaesthetics.
- •2.Unwillingness to participate in the study 3.Infection at injection site 4.Coagulation disorders 5.Liver and kidney disease.
- ••Children with active respiratory tract infection.
- ••Patients having a history of mental retardation/developmental delay.
结局指标
主要结局
To assess the post-operative analgesic efficacy between Caudal epidural block and Retrolaminar block in children undergoing elective unilateral open inguinal hernia repair
时间窗: Post-operative pain will be assessed with FLACC scale at 1,2,4,6,12 and 24 hours post surgery.Rescue analgesia will be given if FLACC score is more than three. For the first 2 hour Fentanyl 1mcg per kg ( every 15 minutes duration) and between 2 to 24 hour, oral Ibuprofen 10 mg per kg (maximum dose 10mg per kg every 8 hour) will be used.
次要结局
- .Adverse events: nausea, vomiting, hypotension, urinary retention