Comparison of Erector Spinae Plane and Paravertebral Nerve Blocks for Postoperative Analgesia in Children After the Nuss Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Pain scores at rest at 24 hours postoperatively
研究概览
简要总结
This is a prospective randomized double-blind non-inferiority trial designed to test the hypothesis that erector spinae plane block (ESPB) is non-inferior to thoracic paravertebral block (TPVB) in postoperative pain control after pectus excavatum repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 4 to 18 years Scheduled for elective Nuss surgery Written informed consent is obtained from parents of each patient.
排除标准
- •Coagulation dysfunction. American Society of Anesthesiologists Physical Status 4 or
- •Allergy to study medication. Local infection at the site of injection or systemic infection. Inability to understand Chinese.
研究组 & 干预措施
ESPB group
0.25% ropivacaine 0.5 ml/kg is injected at the fascial plane deep to the erector spinae muscle
干预措施: ESPB group (Procedure)
TPVB group
0.25% ropivacaine 0.5 ml/kg is injected into the thoracic paravertebral space (T5) using TPVB approach.
干预措施: TPVB group (Procedure)
结局指标
主要结局
Pain scores at rest at 24 hours postoperatively
时间窗: 24 hours postoperatively
Pain scores will be recorded using the Numeric Rating Scale (NRS) scores (0-10).
次要结局
- The pain degree at rest and after movement or coughing(dynamic)(at 3, 6, 12, 24, and 48 hours after surgery)
- total rescue morphine-equivalent consumption per weight(at 24 and 48 hours after surgery)
- Emergence agitation at 5, 15, 30 min after extubation(at 5, 15, 30 min after extubation)
- Total dosage of intraoperative sufentanil and remifentanil(during surgery)
- The time to first analgesia request(within the 3 days after surgery)
- The time to first mobilization(within the 3 days after surgery)
- Side effects(within the 5 days after surgery)
研究者
Min Xu
Department of Anesthesiology, West China Hospital, Sichuan University
West China Hospital