Effects of Extra-fascial Interscalene Brachial Plexus Block on Diaphragmatic Function in School-Aged Children
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To evaluate the rate of diaphragmatic paralysis using ultrasound.
研究概览
简要总结
The traditional intra-fascial interscalene brachial plexus block (ISB) is already one of the routine anesthesia methods for pediatric upper limb surgeries in clinical practice. This study aims to clarify the effect of the extra-fascial interscalene brachial plexus block on the diaphragm function of school-age children, as well as its analgesic effect, and to compare it with the traditional intra-fascial ISB. It intends to explore a more effective and safer ISB method for children. With the aim of optimizing techniques and accurately evaluating, to balance the benefits of analgesia and safety, and thereby promoting the development of precise pediatric anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: School-aged children (6-12 years old).
- •Type of surgery: Upper limb surgery.
- •ASA classification: Grades I-II.
排除标准
- •Infection, anatomical deformity, or tumor at the puncture site.
- •Coagulation disorders (INR > 1.4, platelet count < 100 × 10⁹/L).
- •History of allergy to local anesthetics (ropivacaine).
- •Severe cardiopulmonary or neurological diseases (e.g., epilepsy, myopathy).
- •Pre-existing ipsilateral phrenic nerve paralysis or Horner syndrome.
- •Preoperative long-term use of analgesics (which may affect efficacy assessment).
- •Parent or child refusal to participate in the study.
- •Emergency surgery or inability to cooperate with assessments (e.g., severe developmental delay).
研究组 & 干预措施
intra-fascial interscalene brachial plexus block (ISB)
干预措施: intra-fascial interscalene brachial plexus block (ISB) (Procedure)
extra-fascial interscalene brachial plexus block (ISB)
干预措施: extra-fascial interscalene brachial plexus block (ISB) (Procedure)
结局指标
主要结局
To evaluate the rate of diaphragmatic paralysis using ultrasound.
时间窗: From enrollment to the end of treatment at 2-3 days
次要结局
未报告次要终点
研究者
Jiaqi Shan
anesthesiologist
Shanghai Jiao Tong University Affiliated Sixth People's Hospital