Percutaneous Intercostal Cryoneuromodulation Onset Timing.

NCT ID: NCT07081620

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-07

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cryotherapy Effect Pectus Excavatum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pectus patients

Patients who are eligible for Nuss procedure (for pectus excavatum correction) are undergoing "earlier preoperative percutaneous intercostal cryoneurolysis" in our institution. They are studied through a physical examination also.

Physical examination of chest skin

Intervention Type OTHER

soft touch and thermal (cold and warm) examination

Interventions

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Physical examination of chest skin

soft touch and thermal (cold and warm) examination

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* failure to obtain consent
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Papa Giovanni XXIII Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stefano Mariconti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Papa Giovanni XXIII Hospital

Bergamo, BG, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Stefano Mariconti, MD

Role: CONTACT

00390358347

Facility Contacts

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Stefano Mariconti

Role: primary

References

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Mariconti S, Bronco A, Pellicioli I, Chiudinelli L, Cattaneo M, Cheli M, Bonanomi E. Earlier preoperative percutaneous intercostal cryoanalgesia improves recovery after pectus excavatum surgery. Reg Anesth Pain Med. 2024 Nov 7:rapm-2024-105960. doi: 10.1136/rapm-2024-105960. Online ahead of print.

Reference Type BACKGROUND
PMID: 39510802 (View on PubMed)

Other Identifiers

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PICOT1

Identifier Type: -

Identifier Source: org_study_id

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