Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorPapa Giovanni XXIII Hospital
About this trial
Follow up of patients who underwent percutaneous cryoneurolysis for pectus excavatum repair (the Nuss procedure) pain management
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who underwent percutaneous cryoneurolysis.
Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure.
Signed informed consent.
Disqualifiers
Refusal to participate in the study
Peripheral nervous system disorders
Age < 14 years
Failure to attend scheduled follow-up visits
Trial population
Adolescents older than 14 years and young adults who underwent percutaneous cryoanalgesia between July 1, 2022 and December 31, 2026.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Questionnaire - Pediatric Quality of Life Inventory (PedsQL™) Questionnaire - Patient Self-Assessment Sensory Scale
Diagnostic testAssessment 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)
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patients who underwent percutaneous cryoneurolysis for the Nuss procedure pain management1 intervention
Trial outcomes
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
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.Secondary outcomes
1
Pediatric Quality of Life Inventory (PedsQL) questionnaire
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.
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.2
chronic postoperative pain (CPSP) assessment
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.
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.3
sensitivity recovery using the Patient Self-Assessment Sensory Scale
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov