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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
The Children's Memorial Health Institute
RECRUITING
Warsaw
Time Frame
Start Date: 2025-04-25
Estimated Completion Date: 2026-03
Participants
Target number of participants: 40
Treatments
Experimental: One minute cryoanalgesia
Active_comparator: Two minutes cryoanalgesia
Related Therapeutic Areas
Sponsors
Leads: Children's Memorial Health Institute, Poland

This content was sourced from clinicaltrials.gov