跳至主要内容
临床试验/NCT06935799
NCT06935799招募中不适用

Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery: A Pilot Randomized Controlled Trial

Children's Memorial Health Institute, Poland2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年4月25日最近更新:

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

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

发起方
Children's Memorial Health Institute, Poland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mateusz Ciopiński

Principal Investigator, Department of Pediatric Surgery and Organ Transplantation, CMHI

Children's Memorial Health Institute, Poland

研究点 (2)

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