NCT07431632招募中不适用
Comparative Study of the Efficacy of Intraoperative Intercostal Cryoanalgesia and Thoracic Epidural Block in the Postoperative Period of Minimally Invasive Pectus Excavatum Repair (MIRPE): a Prospective, Randomized Clinical Trial
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Length of stay (LOS)
研究概览
简要总结
The main objective of this study is to compare epidural blockade with cryoanalgesia of the intercostal nerves as an analgesic method in the postoperative period of minimally invasive repair of pectus excavatum (MIRPE).
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
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having pectus excavatum;
- •Having signed the Informed Consent Form for the study.
排除标准
- •Age < 13 years at the time of the procedure;
- •Chronic use of analgesics preoperatively;
- •Pectus carinatum, Poland syndrome, or other chest wall anomalies;
- •Previous pectus excavatum repair by any technique;
- •Previous thoracic surgery;
- •Congenital heart disease;
- •Hemorrhagic dyscrasia;
- •Major anesthetic risk factors or history of previous problems with anesthesia;
研究组 & 干预措施
Intraoperative intercostal cryoanalgesia
Experimental
Intercostal nerve cryoanalgesia with the Cryo-S Painless device from Metrum Cryoflex
干预措施: Cryotherapy (Device)
Thoracic epidural block
Active Comparator
Thoracic epidural block
干预措施: Epidural (Procedure)
结局指标
主要结局
Length of stay (LOS)
时间窗: Perioperative/Periprocedural.
Length of stay (LOS) is measured in days from postoperative day (POD) 0 until discharge from hospital.
次要结局
- Numeric pain scale(Perioperative/Periprocedural)
- Opioid use(Perioperative/Periprocedural)
- Postoperative complications(30 days post-surgery.)
- Readmissions to the emergency room or hospital readmission(Within 30 days after surgery)
- Frequency of neuropathic pain(Up to 1 year post-surgery.)
- Satisfaction with the post-operative result(Single evaluation during the outpatient follow-up 6 months after surgery.)
- Cost of hospitalization (in Brazilian Real)(Perioperative/Periprocedural)
研究者
Miguel L. Tedde
Principal Investigator
University of Sao Paulo
研究点 (1)
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