Clinical Trial

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

Study acronym: Cryo-One
Recruiting
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Record status
This record was last updated May 1, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-13.
Status change: Not Yet Recruiting → Recruiting 2025-04-28
Trial Details
NCT Number NCT06935799
Lead Sponsor Children's Memorial Health Institute, Poland
Conditions Pectus Excavatum, Funnel Chest
Enrollment 40 participants
Start Date 2025-04-25
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-05-01