NCT06682208招募中不适用
Prospective Randomized Trial of Efficacy and Safety of Erector Spinae Catheter and Intercostal Nerve Cryoablation Protocols After Pectus Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Compare time to reach discharge
研究概览
简要总结
Participants will be randomized to receive ES catheter or cryoablation for pain management after the Nuss procedure. The goal of this study is to compare the following between the two groups:
- Time to achieve short-term physical therapy goals and long-term functional outcomes
- Compare immediate and long-term postoperative opioid use
- Compare numbness on chest of postoperative day 1 and the return of sensation to baseline
- Compare the incidence of neuropathic pain and other complications
Participants will receive surveys for up to 12 months postoperatively.
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
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 - 21 years
- •History of pectus excavatum
- •Scheduled for Nuss procedure
排除标准
- •Prior pectus repair
- •Other concomitant surgeries
- •Chronic pain conditions including Ehlers Danlos Syndrome
- •Non-English speaking - rationale: the questionnaires used in the study are in English language and the social and cultural factors of pain perception of non-English speaking patients could affect the study power
- •Severe developmental delays including cognitive (difficulties understanding), motor (cerebral palsy or muscular dystrophy), and speech delays (difficulties communicating)
- •History of or active renal or liver disease
- •Major surgery requiring opioids in the last 2 years
- •Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month)
- •Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, uncontrolled hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included
- •Pregnant or breastfeeding females
结局指标
主要结局
Compare time to reach discharge
时间窗: Day of surgery up tp 10 days post-operative
Comparing physical therapy goals to meet discharge criteria.
次要结局
- Opioid consumption(Day of surgery to up to one year)
- Numbness on chest(Day of surgery and post-operative day 1)
- Neuropathic pain(Pre-operative, 6 weeks, 2-3 months, 4-6 months and 10-12 months post-operatively)
- Opioid consumption(Day of surgery to up to one year)
- Numbness on chest(Day of surgery and post-operative day 1)
- Neuropathic pain(Pre-operative, 6 weeks, 2-3 months, 4-6 months and 10-12 months post-operatively)
研究者
研究点 (2)
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