An interventional study of One minute intercostal nerves cryoanalgesia and Two minutes intercostal nerves cryoanalgesia in Pectus Excavatum and Funnel Chest, sponsored by Children's Memorial Health Institute, Poland. Recruiting at 1 site in Poland. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Children's Memorial Health Institute, Poland · Not applicable, Interventional, and Treatment
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →Children's Memorial Health Institute, Poland is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: One minute intercostal nerves cryoanalgesia
Procedure: Two minutes intercostal nerves cryoanalgesia
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
Postoperative pain level according to Numerical Rating Scale (NRS)
Time frame: 1 week
Opioid consumption
Time frame: 1 week
Duration of the surgery
Time frame: 1 day
Length of postoperative hospital stay
Time frame: 1 week
Occurence of early complications
Time frame: 30 days from the surgery
Started Apr 2025 (actual). Primary completion is estimated for Mar 2026, 11 months after the start.
Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 11 months is below that.
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Children's Memorial Health Institute, Poland