Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Postoperative pain level according to Numerical Rating Scale (NRS)
研究概览
简要总结
Intercostal nerve cryoanalgesia has become a popular method for managing postoperative pain after Nuss procedure, showing greater effectiveness compared to epidural anesthesia and patient-controlled analgesia. However, the optimal duration of cryoanalgesia remains unknown. Most protocols use a two-minute cryoablation, although histological studies show similar changes with both one-minute and two-minute applications.
This is a pilot, single-center, randomized, double-blind study comparing the effectiveness of one-minute versus two-minute cryoanalgesia in treating pain in patients undergoing correction of pectus excavatum using the Nuss procedure. The aim of the project is to evaluate the validity of the research procedure and determine the sample size for the main study. Preliminary data on postoperative pain intensity, opioid consumption, duration of surgery, length of hospital stay, and complications will be analyzed.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pectus excavatum repair with MIRPE
- •Written consent for corrective surgery with intraoperative cryoanalgesia
- •Written consent to participate in the study
- •Age >12 and < 18 years
排除标准
- •History of previous thoracic surgeries
- •Reoperation for chest deformity
- •Contraindication for cryoanalgesia
- •Presence of other conditions that may affect the course of the procedures and the assessment of their effectiveness and safety
结局指标
主要结局
Postoperative pain level according to Numerical Rating Scale (NRS)
时间窗: 1 week
次要结局
- Length of postoperative hospital stay(1 week)
- Opioid consumption(1 week)
- Duration of the surgery(1 day)
- Occurence of early complications(30 days from the surgery)
研究者
Mateusz Ciopiński
Principal Investigator, Department of Pediatric Surgery and Organ Transplantation, CMHI
Children's Memorial Health Institute, Poland
