Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery

NCT06935799 — Not applicable, Recruiting, 40 participants, Children's Memorial Health Institute, Poland

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Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery: A Pilot Randomized Controlled Trial

Registry	NCT06935799, acronym Cryo-One
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	40 (Estimated)
Sponsor	Children's Memorial Health Institute, Poland (Other)
Conditions	Pectus Excavatum, Funnel Chest
Interventions	One minute intercostal nerves cryoanalgesia, Two minutes intercostal nerves cryoanalgesia (Procedure)
Dates	start 2025-04-25, primary completion 2026-03-01 (estimated), completion 2026-03-01 (estimated), first posted 2025-04-20, last updated 2025-05-01
Locations	1 site in Poland

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
One minute cryoanalgesia	Experimental	Procedure: One minute intercostal nerves cryoanalgesia
Two minutes cryoanalgesia	Active comparator	Procedure: Two minutes intercostal nerves cryoanalgesia

One minute intercostal nerves cryoanalgesia (Procedure): One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Two minutes intercostal nerves cryoanalgesia (Procedure): Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7

+Outcome measures

Primary outcomes

Postoperative pain level according to Numerical Rating Scale (NRS) [1 week]

Secondary outcomes

Opioid consumption [1 week]
Duration of the surgery [1 day]
Length of postoperative hospital stay [1 week]
Occurence of early complications [30 days from the surgery]

+Eligibility

Sex: All, ages: 12 Years to 18 Years

Inclusion Criteria:

* 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 Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
The Children's Memorial Health Institute	Warsaw, Wybierz Województwo	Poland	Recruiting