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NCT Number: NCT07081620

Percutaneous Intercostal Cryoneuromodulation Onset Timing.

Percutaneous Intercostal Cryoneurolysis is a promising technique that addresses acute postoperative pain after Nuss procedure for pectus excavatum. However its onset timing has not yet been determined. A physical examination would assess the variation of chest skin sensitivity to soft touch, cold (water at 4°C), and heat (water at 40°C) through days following the cryoneurolysis procedure.

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Key information

Conditions

Cryotherapy Effect Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases Pectus Excavatum

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Papa Giovanni XXIII Hospital

Bergamo, BG, 24100, Italy

Location status: Recruiting

Location contact

Stefano Mariconti

CONTACT

Stefano Mariconti, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who are undergoing preoperative percutaneous intercostal cryoneurolysis for pectus excavatum surgery

Exclusion criteria

  • failure to obtain consent

Treatment and study plan

Physical examination of chest skin

Other

soft touch and thermal (cold and warm) examination

Primary outcomes

  1. thermal sensitivity

    Time frame: one week (median)

    Chest skin thermal sensitivity will be assessed through a "thermofeel" metal instrument set at two different temperatures: 15°C for cold sensation and 40°C for warm sensation. At least 4 different chest zones will be tested to discriminate potential differences. As a validated instument for chest skin thermal assessment does not exist, we will report only qualitative results, as "normal" "impaired" or "absent" sensitivity.

Secondary outcomes

  1. chest skin sensitivity to touch

    Time frame: one week (median)

    Chest skin mechanical sensitivity will be assessed through both validated von Frey filament testing, and cotton swab for soft touch. At least 4 different chest zones will be tested to discriminate potential differences. We will report qualitative results, as "normal" "impaired" or "absent" sensitivity.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Mariconti, MD

CONTACT

[email protected]

00390358347

Sponsors and collaborators

Lead sponsor

Papa Giovanni XXIII Hospital

Other

Registry information

Official study title

How Long Does it Take for Percutaneous Intercostal Cryoneuromodulation to Produce Cryoanalgesia? A Prospective Observational Study.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
Jul 23, 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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