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

April 28, 2025 updated by: Mateusz Ciopiński, Children's Memorial Health Institute, Poland

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Wybierz województwo
      • Warsaw, Wybierz województwo, Poland, 02-829
        • Recruiting
        • The Children's Memorial Health Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One minute cryoanalgesia
Procedure: One minute intercostal nerves cryoanalgesia
One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Active Comparator: Two minutes cryoanalgesia
Procedure: Two minutes intercostal nerves cryoanalgesia
Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain level according to Numerical Rating Scale (NRS)
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of the surgery
Time Frame: 1 day
1 day
Opioid consumption
Time Frame: 1 week
1 week
Length of postoperative hospital stay
Time Frame: 1 week
1 week
Occurence of early complications
Time Frame: 30 days from the surgery
30 days from the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Memorial Health Institute, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 13, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37/KBE/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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