Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery (Cryo-One)

Children's Memorial Health Institute, Poland

Status

Enrolling

Conditions

Funnel Chest

Pectus Excavatum

Treatments

Procedure: Two minutes intercostal nerves cryoanalgesia

Procedure: One minute intercostal nerves cryoanalgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT06935799

37/KBE/2024

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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