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

Study acronym: Cryo-One
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2025 to Apr 25, 2025
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06935799
Lead Sponsor Children's Memorial Health Institute, Poland
Conditions
(from sponsor)		 Pectus Excavatum, Funnel Chest
Related terms Agnosia, Funnel Chest
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov