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RECRUITING
NCT06935799
NA

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

Sponsor: Children's Memorial Health Institute, Poland

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-04-25

Completion Date

2026-03

Last Updated

2025-05-01

Healthy Volunteers

No

Interventions

PROCEDURE

One minute intercostal nerves cryoanalgesia

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

PROCEDURE

Two 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