Percutaneous Intercostal Cryoneuromodulation Onset Timing.

NCT07081620 | Recruiting

• 1 other identifier: PICOT1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryotherapy Effect; Pectus Excavatum

Keywords

Cryoneurolysis; Cryoneuromodulation

Outcome Measures

Primary Outcomes (1)

• thermal sensitivity

  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.

  one week (median)

Secondary Outcomes (1)

• chest skin sensitivity to touch

  one week (median)

Study Arms (1)

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.

Other: Physical examination of chest skin

Interventions

Physical examination of chest skin OTHER

soft touch and thermal (cold and warm) examination

Pectus patients

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mainly adolescents, mainly males

You may qualify if:

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

You may not qualify if:

• failure to obtain consent

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Papa Giovanni XXIII Hospital

Bergamo, BG, 24100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 39510802 BACKGROUND

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Stefano Mariconti, MD

CONTACT

00390358347; smariconti@asst-pg23.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 23, 2025
• Study Start: June 7, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

IT (1)