The Comparison of Pericapsular Nerve Block and Fascia Iliaca Compartment Block in Children With Cerebral Palsy or Spina Bifida for Pain Management in Hip Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Opioids consumption
研究概览
简要总结
The goal of this clinical trial is to test the hypothesis that performing a Pericapsular nerve group (PENG) block allows for more effective analgesia in the perioperative period during reconstructive surgery on the hip in children with cerebral palsy and spina bifida compared with Fascia illiaca compartment block (FICB).
详细描述
The main question it aims to answer is: Is the PENG block an effective and safe method of pain relief for hip surgery in children? Participants will be randomized into two equal groups. The group who underwent US - guided PENG block, and the group who underwent US - guided FICB . In both groups we used 0.5% ropivacaine. The same postoperative analgesia regimen was applied by intravenous acetaminophen , oral ibuprofen . In case of ineffectiveness of the prescribed drugs, promedol was used intramuscularly. The postoperative consumption of promedol, time to first rescue analgesia, numerical pain score (NRS) (for children from 7 years old), FLACC score, measurements of A.N.I. monitor MDMS and the side effects will be recorded
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
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •reconstructive surgery on the hip joint
- •children with cerebral palsy/ spina bifida/organic brain injury
- •age 3 - 18 years.
排除标准
- •contraindications to the use of local anesthetics
- •contraindications to performing an invasive procedure
结局指标
主要结局
Opioids consumption
时间窗: 24 hours
Total dosage of opioids in postoperative period
次要结局
- Time to rescue analgesia(24 hours)
- Pain level(2, 6, 12, 24 hours after completing the block)
- Intraoperative level of analgesia(Intraoperatively)
- Time to rescue analgesia(24 hours)
- Pain level(2, 6, 12, 24 hours after completing the block)
- Intraoperative level of analgesia(Intraoperatively)
研究者
Novikova Veronika
Principal Investigator
Saint Petersburg State University, Russia