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
Children's Memorial Health Institute, Poland
40 participants
Apr 25, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06935799