Actively Recruiting
Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery
Led by Children's Memorial Health Institute, Poland · Updated on 2025-05-01
40
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pectus excavatum repair with minimally invasive repair of pectus excavatum (MIRPE)
- Written consent for corrective surgery with intraoperative cryoanalgesia
- Written consent to participate in the study
- Age greater than 12 and less than 18 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Children's Memorial Health Institute
Warsaw, Wybierz Województwo, Poland, 02-829
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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