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NCT Number: NCT06935799

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

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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Key information

Conditions

Pectus Excavatum Agnosia Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Memorial Health Institute

Warsaw, Wybierz Województwo, 02-829, Poland

Location status: Recruiting

Location contact

Mateusz Ciopiński, MD, PhD

CONTACT

[email protected]

0048228151360

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Postoperative pain level according to Numerical Rating Scale (NRS)

    Time frame: 1 week

Secondary outcomes

  1. Opioid consumption

    Time frame: 1 week

  2. Duration of the surgery

    Time frame: 1 day

  3. Length of postoperative hospital stay

    Time frame: 1 week

  4. Occurence of early complications

    Time frame: 30 days from the surgery

Sponsors and collaborators

Lead sponsor

Children's Memorial Health Institute, Poland

Other

Registry information

Official study title

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

Acronym: Cryo-One

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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