RecruitingNot ApplicableNCT06935799

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


Sponsor

Children's Memorial Health Institute, Poland

Enrollment

40 participants

Start Date

Apr 25, 2025

Study Type

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

Min Age: 12 YearsMax Age: 18 Years

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

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Interventions

PROCEDUREOne minute intercostal nerves cryoanalgesia

One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7

PROCEDURETwo minutes intercostal nerves cryoanalgesia

Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7


Locations(1)

The Children's Memorial Health Institute

Warsaw, Wybierz Województwo, Poland

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NCT06935799


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