RecruitingNCT07657845

Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis

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

Pectus Surgery Cryo Analgesia

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_TESTSelf-report Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Questionnaire - Pediatric Quality of Life Inventory (PedsQL™) Questionnaire - Patient Self-Assessment Sensory Scale

Assessment tools include validated questionnaires - the S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs, range 0-24, higher scores indicating greater likelihood of neuropathic pain) and the PedsQL™ (Pediatric Quality of Life Inventory, v4.0, Adolescent/Young Adult Report, range 0-100, higher scores indicating better health-related quality of life) - together with the Patient Self-Assessment Sensory Scale (range 0-10, 0 indicating no sensitivity and 10 indicating normal sensitivity) and a structured physical examination of thoracic sensitivity. These tools are administered at pre-specified follow-up timepoints. The physical examination assesses four sensory modalities corresponding to specific afferent fibre classes of the intercostal nerves: cold thermal sensation (Aδ fibres, ice-water contact, 4-10°C), warm thermal sensation (C fibres, \~40°C water), light touch (Aβ fibres, camel-hair brush), and pressure sensitivity (Aβ fibres, Von Frey filament 5.07/10g)