About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
One minute intercostal nerves cryoanalgesia
Procedure/SurgeryOne-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Two minutes intercostal nerves cryoanalgesia
Procedure/SurgeryTwo-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Treatment groups
Trial outcomes
Primary outcomes
Postoperative pain level according to Numerical Rating Scale (NRS)
Secondary outcomes
Opioid consumption
Duration of the surgery
Length of postoperative hospital stay
Occurence of early complications
Sponsors and contacts
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