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Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery

RecruitingNAAges 12 Years - 18 YearsAllChildren's Memorial Health Institute, Poland
NCT06935799 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, a

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • One minute intercostal nerves cryoanalgesia
  • Two minutes intercostal nerves cryoanalgesia
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Where

1 site
The Children's Memorial Health Institute
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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