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NCT Number: NCT07657845

Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis

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

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Key information

Conditions

Cryo Analgesia Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Pectus Surgery Peripheral Nervous System Diseases Signs and Symptoms

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

Location status: Recruiting

Location contact

Stefano Mariconti, MD

CONTACT

[email protected]

0039 + 0352675149

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Mariconti, MD

CONTACT

[email protected]

0039 + 0352675149

Sponsors and collaborators

Lead sponsor

Papa Giovanni XXIII Hospital

Other

Registry information

Official study title

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

Acronym: CRYOFUP

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Jun 18, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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