Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis

NCT07657845 | Recruiting

• 1 other identifier: CRYOFUP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cryo Analgesia; Pectus Surgery

Keywords

follow up; lanss; neuropathy; chronic pain; cpsp; neuropathic pain; sensitivity recovery; PedsQL

Outcome Measures

Primary Outcomes (1)

• Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire results

  To assess the incidence of neuropathic pain using the validated S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs) scale, administered at the scheduled follow-up visits. The S-LANSS score ranges from 0 to 24, with higher scores indicating greater likelihood and severity of neuropathic pain (a score ≥12 is suggestive of pain of predominantly neuropathic origin

  The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how S-LANSS score evolve over time.

Secondary Outcomes (3)

• Pediatric Quality of Life Inventory (PedsQL) questionnaire

  The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how quality of life evolve over time.

• chronic postoperative pain (CPSP) assessment

  The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how chronic pain evolve over time.

• sensitivity recovery using the Patient Self-Assessment Sensory Scale

  The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how sensitivity recovery evolve over time.

Study Arms (1)

Patients who underwent percutaneous cryoneurolysis for the Nuss procedure pain management

All patients who underwent surgical correction of pectus excavatum via the Nuss procedure between July 1, 2022 and February 28, 2026 are considered eligible for enrollment. Additionally, for the prospective component, patients scheduled for surgery up to December 31, 2026 at the Pediatric Surgery department of our institution will be considered eligible. Inclusion criteria: Age greater than 14 years. Patients who underwent percutaneous cryoneurolysis. Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure. Exclusion criteria: Patients who withhold consent to participate in the study, patients with pre-existing neurological conditions, and patients who do not attend the scheduled follow-up visits will be excluded from the study.

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

Interventions

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

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)

Patients who underwent percutaneous cryoneurolysis for the Nuss procedure pain management

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents older than 14 years and young adults who underwent percutaneous cryoanalgesia between July 1, 2022 and December 31, 2026.

You may qualify if:

• Patients who underwent percutaneous cryoneurolysis.
• Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure.
• Signed informed consent.

You may not qualify if:

• Refusal to participate in the study
• Peripheral nervous system disorders
• Age \< 14 years
• Failure to attend scheduled follow-up visits

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

ASST Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Ezio Bonanomi, MD

  Department of Anesthesia and Intensive Care, Paediatric Anesthesiology and Intensive Care Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.

  STUDY CHAIR

Central Study Contacts

Stefano Mariconti, MD

CONTACT

0039 + 0352675149; smariconti@asst-pg23.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologist

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: February 2, 2025
• Primary Completion: June 13, 2026
• Study Completion (Estimated): January 15, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

IT (1)