Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis (CRYOFUP)

June 17, 2026 updated by: Stefano Mariconti, Papa Giovanni XXIII Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Follow up of patients after receiving percutaneous cryoneurolysis for pectus excavatum repair, who undergo a physical examination and a neurosensory assessment of the chest wall at 1, 3, 6, 12, and 24 months postoperatively, corresponding to the scheduled follow-up visits. In addition, to evaluate neuropathic pain, chronic pain, and quality of life, patients complete validated questionnaires.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • BG
      • Bergamo, BG, Italy, 24127
        • Recruiting
        • ASST Papa Giovanni XXIII
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire results
Time Frame: The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how S-LANSS score evolve over time.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Quality of Life Inventory (PedsQL) questionnaire
Time Frame: The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how quality of life evolve over time.
To describe the quality of life of patients using a specific validated questionnaire appropriate for adolescents and young adults (Pediatric Quality of Life Inventory - PedsQL™ version 4.0 for adolescents and young adults). The PedsQL total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
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
Time Frame: The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how chronic pain evolve over time.
To describe the incidence of chronic postoperative pain (CPSP), defined as persistence of pain beyond one month, according to two parameters: direct measurement using the NRS (Numeric Rating Scale) for pain intensity, and indirect measurement through consumption of analgesic medications included in the institutional current protocol (acetaminophen and NSAIDs). The NRS ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain intensity.
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
Time Frame: The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how sensitivity recovery evolve over time.
To describe the evolution of thoracic thermotactile hypoesthesia over time, starting from the day of cryoneurolysis, using the Patient Self-Assessment Sensory Scale. The scale ranges from 0 to 10, with 0 indicating no sensitivity (complete anaesthesia) and 10 indicating maximal/normal sensitivity, with higher scores indicating better (more complete) sensory recovery.
The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how sensitivity recovery evolve over time.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papa Giovanni XXIII Hospital

Investigators

  • Study Chair: Ezio Bonanomi, MD, Department of Anesthesia and Intensive Care, Paediatric Anesthesiology and Intensive Care Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2025

Primary Completion (Actual)

June 13, 2026

Study Completion (Estimated)

January 15, 2029

Study Registration Dates

First Submitted

June 13, 2026

First Submitted That Met QC Criteria

June 13, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRYOFUP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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