Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery
NCT ID: NCT06935799
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-04-25
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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One minute cryoanalgesia
One minute intercostal nerves cryoanalgesia
One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Two minutes cryoanalgesia
Two minutes intercostal nerves cryoanalgesia
Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Interventions
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One minute intercostal nerves cryoanalgesia
One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Two minutes intercostal nerves cryoanalgesia
Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Eligibility Criteria
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Inclusion Criteria
* Written consent for corrective surgery with intraoperative cryoanalgesia
* Written consent to participate in the study
* Age \>12 and \< 18 years
Exclusion Criteria
* 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
12 Years
18 Years
ALL
No
Sponsors
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Children's Memorial Health Institute, Poland
OTHER
Responsible Party
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Mateusz Ciopiński
Principal Investigator, Department of Pediatric Surgery and Organ Transplantation, CMHI
Locations
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The Children's Memorial Health Institute
Warsaw, Wybierz Województwo, Poland
Countries
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Facility Contacts
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Other Identifiers
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37/KBE/2024
Identifier Type: -
Identifier Source: org_study_id
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