Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Analgesia requirement
研究概览
简要总结
The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia.
详细描述
Rectal biopsies in pediatric patients are performed under general anesthesia to obtain adequate tissue samples and optimize for patient comfort, well-being and safety. Post-operative pain can persist for longer than a day and requires analgesics. This study aimed to evaluate the effectiveness of sacral erector spinae block in decreasing post-operative pain scores and analgesic requirements.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing only rectal biopsy
- •ASA class I-II
排除标准
- •ASA class III or more
- •Coagulation disorders
- •Sacral or spinal anatomical abnormalities
- •Infection around the block site
- •Local anesthesia allergy
结局指标
主要结局
Analgesia requirement
时间窗: Post operative 24 hours
If CHIPPS(Children's and Infant's Postoperative Pain Scale- minimum score is 0, maximum score is 10) score \> 4, patient will receive 1mg/kg tramadol during the first post-operative hour. If CHIPPS score \> 4 after 1st hour, patient will receive 10mg/kg paracetamol initially and if further assessment 30 min later is still \>4 patient will receive additional 1mg/kg tramadol
Postoperative pain scores
时间窗: Postoperative 30th minute, 1st hour, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hour
Children's and Infant's Postoperative Pain Scale (CHIPPS) assessment of postoperative pain (Scores between 0 and 3 indicate no pain, and scores above 4 indicate the need for pain management.)( minimum score is 0, maximum score is 10)
次要结局
- Complications(Post-operative 24 hours)
研究者
pinar kendigelen
Associate Professor
Istanbul University - Cerrahpasa (IUC)