Comparison of Analgesic Efficacy Between Ultrasound-Guided low dose Caudal Epidural Block versus Dorsal Penile Nerve Block in Pediatric patients undergoing Circumcision
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To determine the duration of pain relief by assessing the time until the first additional analgesic dose is required.
研究概览
简要总结
This prospective, randomized, parallel-group controlled trial aims to compare the analgesic efficacy of ultrasound-guided caudal epidural block versus dorsal penile nerve block (DPNB) in paediatric patients undergoing circumcision. Fifty ASA I–II male children aged 5–9 years will be randomly allocated into two groups (n=25 each). Group C will receive ultrasound-guided caudal epidural block with 0.25% ropivacaine (0.5 ml/kg), while Group D will receive ultrasound-guided DPNB with 0.25% ropivacaine (0.5 ml/kg), administered after induction of anaesthesia and before extubation. The primary outcome will be time to first rescue analgesia. Secondary outcomes will include postoperative FLACC pain scores over 24 hours, total rescue analgesic consumption, and incidence of adverse effects. Data will be analysed using SPSS v21, with p < 0.05 considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male children aged 5 to 9 years 2.ASA physical status I or II 3.Scheduled for elective circumcision 4.Written informed consent obtained from parents or guardians.
排除标准
- •1.ASA physical status III or higher 2.Known allergy or contraindication to local anesthetics 3.Coagulopathy or bleeding disorders 4.Infection at injection site 5.Congenital anomalies of sacrum or spine (for caudal block) 6.Neurological or developmental disorders 7.Parental refusal for participation.
结局指标
主要结局
To determine the duration of pain relief by assessing the time until the first additional analgesic dose is required.
时间窗: FLACC SCORE at 1hour,4 hours, 8hours,12 hours,16 hours, 24 hours
次要结局
- 1.Analgesic consumption(2. Adverse effects)
研究者
Dr SUDHEER R
Rajarajeswari medical college and hospital