RecruitingNCT07657845

Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis: Neuropathic Pain, Quality of Life and Sensory Recovery in a Paediatric Cohort Following Pectus Excavatum Repair


Sponsor

Papa Giovanni XXIII Hospital

Enrollment

50 participants

Start Date

Feb 2, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Follow up of patients who underwent percutaneous cryoneurolysis for pectus excavatum repair (the Nuss procedure) pain management


Eligibility

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Questionnaire and Physical Exam for people with cryo analgesia and pectus surgery. The study is currently recruiting participants at 1 location. People eligible for this study include aged 14 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTQuestionnaire and Physical Exam

Assessment tools include validated questionnaires (S-LANSS and PedsQL) and a structured physical examination of thoracic sensitivity. These tools are administered at pre-specified follow-up appointments (timepoints). The sensory physical examination is conducted using four standardized stimuli, selected to systematically assess each class of afferent nerve fibers of the intercostal nerves. For cold thermal sensation (Aδ fibers), a latex glove containing an ice-water mixture (4-10°C) is applied in contact with the skin over predetermined anterior thoracic areas. For warm thermal sensation (unmyelinated C fibers), an analogous container filled with water at approximately 40°C, heated using a bottle warmer, is employed. Tactile sensitivity (Aβ fibers) is assessed using a standardized camel-hair neurological brush for light touch, and Von Frey filaments (5.07/10 grams) for pressure sensitivity.


Locations(1)

ASST Papa Giovanni XXIII

Bergamo, BG, Italy

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NCT07657845


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