NCT06935799

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Children's Memorial Health Institute, Poland · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pectus Excavatum
• Funnel Chest

Interventions

Type	Name	Description
PROCEDURE	One minute intercostal nerves cryoanalgesia	One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
PROCEDURE	Two minutes intercostal nerves cryoanalgesia	Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7

Timeline

• Start date: 2025-04-25
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-04-20
• Last updated: 2025-05-01

Locations

1 site across 1 country: Poland