Percutaneous Intercostal Cryoneuromodulation Onset Timing.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-40
SponsorPapa Giovanni XXIII Hospital
About this trial
Percutaneous Intercostal Cryoneurolysis is a promising technique that addresses acute postoperative pain after Nuss procedure for pectus excavatum. However its onset timing has not yet been determined. A physical examination would assess the variation of chest skin sensitivity to soft touch, cold (water at 4°C), and heat (water at 40°C) through days following the cryoneurolysis procedure.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients who are undergoing preoperative percutaneous intercostal cryoneurolysis for pectus excavatum surgery
Disqualifiers
failure to obtain consent
Trial population
Mainly adolescents, mainly males
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Physical examination of chest skin
Other interventionsoft touch and thermal (cold and warm) examination
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Pectus patients1 intervention
Trial outcomes
Primary outcomes
1
thermal sensitivity
Chest skin thermal sensitivity will be assessed through a "thermofeel" metal instrument set at two different temperatures: 15°C for cold sensation and 40°C for warm sensation. At least 4 different chest zones will be tested to discriminate potential differences. As a validated instument for chest skin thermal assessment does not exist, we will report only qualitative results, as "normal" "impaired" or "absent" sensitivity.
Time frame
one week (median)Secondary outcomes
1
chest skin sensitivity to touch
Chest skin mechanical sensitivity will be assessed through both validated von Frey filament testing, and cotton swab for soft touch. At least 4 different chest zones will be tested to discriminate potential differences. We will report qualitative results, as "normal" "impaired" or "absent" sensitivity.
Time frame
one week (median)Sponsors and contacts
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Source ClinicalTrials.gov