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临床试验 NCT06210503 针对围手术期镇痛，Hip Dislocation, Developmental目前进行中（不再招募）。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
PENG Block in Comparison With FICB for Hip Reconstruction in Children 86
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临床试验NCT06210503是一项针对围手术期镇痛，Hip Dislocation, Developmental的干预性研究试验，目前试验状态为进行中（不再招募）。试验始于2023年12月4日，计划招募86名患者。该研究由Saint Petersburg State University, Russia主导，预计于2025年11月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年7月8日。
简要概括
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...显示更多
官方标题
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.
疾病
围手术期镇痛Hip Dislocation, Developmental其他研究标识符
- PENG vs FICB
NCT编号
实际开始日期
2023-12-04
最近更新发布
2025-07-08
预计完成日期
2025-11-01
计划入组人数
86
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中（不再招募）
关键词
Anesthesia local
nerve block
postoperative pain
hip dislocation
children
nerve block
postoperative pain
hip dislocation
children
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照PENG group The patient will undergo pericapsular nerve blockade with 0.5% ropivacaine based on 3 mg/kg ropivacaine using ultrasound scanning. | Pericapcelar group nerve block In the supine position, a high-frequency linear sensor is placed in the anterior superior iliac spine and then aligned with the ramus of the pubis by rotating the probe counterclockwise approximately 45 degrees. The iliopsoas muscle and tendon, femoral artery, and pectineus muscle were observed in this view.The iliopsoas muscle and its tendon are visualized, as well as the vascular and nerve bundle: femoral artery, v...显示更多 |
阳性对照FICB group The patient will undergo FICB with 0.5% ropivacaine based on 3 mg/kg ropivacaine using ultrasound scanning. | 髂筋膜间隙阻滞 In the supine position, a high-frequency linear sensor is placed in the inguinal fold. Scan starting lateral to the femoral artery and the nerve in the inguinal crease to identify the sartorius muscle, tracing the muscle to its origin to the anterior superior iliac spine. A shadow of the iliac crest bone and iliacus muscle will be visible, with the end point of injection being deep in the fascia iliaca and above the ...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Opioids consumption | Total dosage of opioids in postoperative period | 24 hours |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Time to rescue analgesia | Time to first accepted of opioid analgesia | 24 hours |
Pain level | Assessing level of pain. Using pain scales. Face, Legs, Activity, Cry, Consolability (FLACC) scale for children from 3 to 7 years old. The scale is scored in a range of 0-10 with 0 representing no pain, and 10 representing maximal pain. The numeric rating scale (NRS) is a verbal or written determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain.
Analgesia-nociception index (ANI). Using "ANI Monitor". | 2, 6, 12, 24 hours after completing the block |
Intraoperative level of analgesia | Analgesia-nociception index (ANI). Using "ANI Monitor". | Intraoperatively |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
3 Years
适龄性别
全部
- reconstructive surgery on the hip joint
- children with cerebral palsy/ spina bifida/organic brain injury
- age 3 - 18 years.
- contraindications to the use of local anesthetics
- contraindications to performing an invasive procedure
- ASA > 3
Saint Petersburg State University, Russia研究责任方
Novikova Veronika, 主要研究者, Principal Investigator, Saint Petersburg State University, Russia
没有联系数据。
1 位于 1 个国家/地区的研究中心
Saint-Petersburg State University, Saint Petersburg, Russia