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Percutaneous Intercostal Cryoneuromodulation Onset Timing.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07081620
Enrollment
20
Registered
2025-07-23
Start date
2025-06-07
Completion date
2026-11-30
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryotherapy Effect, Pectus Excavatum

Keywords

Cryoneurolysis, Cryoneuromodulation

Brief summary

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.

Interventions

OTHERPhysical examination of chest skin

soft touch and thermal (cold and warm) examination

Sponsors

Papa Giovanni XXIII Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* failure to obtain consent

Design outcomes

Primary

MeasureTime frameDescription
thermal sensitivityone 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

MeasureTime frameDescription
chest skin sensitivity to touchone 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.

Countries

Italy

Contacts

Primary ContactStefano Mariconti, MD
smariconti@asst-pg23.it00390358347

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026