The Optimization of the Intercostal Nerves Cryoablation Aplication Time During Nuss Procedure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The worse pain occurrence during first 24 hours after operation.
研究概览
简要总结
This study compared standard therapy (multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in subject undergoing minimal invasive modyfied Nuss procedure with thoracoscopy.
详细描述
Funnel chest deformation may be a great challenge for therapeutic teams due to severe pain in the postoperative period as well as chronic pain.
2 minutes per one intercostal nerve aplication cryoanalgesia as a part of multimodal analgesia is a standard protocol in many countries.
This Prospective Non-Randomized Study is a single institution pilot study designed to compare standard therapy (control side: multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in each patient to address the need for better management of acute and long-term pain in the pediatric population diagnosed with funnel-chest and treated using the modyfied Nuss method.
All of the patients will receive a standard care according to Polish guidelines: multimodal analgesia with regional analgesia (bilateral erector spine plane block) with cryoanalgesia. The right intercostal nerves will be treated with 2 minutes cryoanalgesia (control side). The left side of the chest (left intercostal nerves) will be treated with 1 minute cryoanalgesia (intervention side).
The intraoperative cryoanalgesia will be performed using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic Nuss technique
- •informed concent signed for cryolesia
排除标准
- •age 9 years or below
- •refuse to receive cryoanalgesia or regional anaesthesia as a primary pain relief
结局指标
主要结局
The worse pain occurrence during first 24 hours after operation.
时间窗: up to 24 hours after operation
numeric pain score, range from 0 to 10
次要结局
- residual wound or chest pain occurrence(postoperative months 1,3)
- thoracic hypoaesthesia occurrence(up to 24 hours after operation)
- duration of hospitalization(estimated 4 days)