How Long Does it Take for Percutaneous Intercostal Cryoneuromodulation to Produce Cryoanalgesia? A Prospective Observational Study.
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
- 1
- 主要终点
- thermal sensitivity
研究概览
简要总结
Percutaneous Intercostal Cryoneurolysis is a promising technique that addresses acute postoperative pain after Nuss procedure for pectus excavatum. However its onset timing has not yet been determined. A physical examination would assess the variation of chest skin sensitivity to soft touch, cold (water at 4°C), and heat (water at 40°C) through days following the cryoneurolysis procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are undergoing preoperative percutaneous intercostal cryoneurolysis for pectus excavatum surgery
排除标准
- •failure to obtain consent
结局指标
主要结局
thermal sensitivity
时间窗: one week (median)
Chest skin thermal sensitivity will be assessed through a "thermofeel" metal instrument set at two different temperatures: 15°C for cold sensation and 40°C for warm sensation. At least 4 different chest zones will be tested to discriminate potential differences. As a validated instument for chest skin thermal assessment does not exist, we will report only qualitative results, as "normal" "impaired" or "absent" sensitivity.
次要结局
- chest skin sensitivity to touch(one week (median))
研究者
Stefano Mariconti
Principal Investigator
Papa Giovanni XXIII Hospital