An interventional study of Cryotherapy and Epidural in Funnel Chest, Pectus Excavatum and Postoperative Pain After Video Assisted Thoracic Surgery, sponsored by University of Sao Paulo. Recruiting at 1 site in Brazil. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
The main objective of this study is to compare epidural blockade with cryoanalgesia of the intercostal nerves as an analgesic method in the postoperative period of minimally invasive repair of pectus excavatum (MIRPE).
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intercostal nerve cryoanalgesia with the Cryo-S Painless device from Metrum Cryoflex
Device: Cryotherapy
Thoracic epidural block
Procedure: Epidural
Intraoperative intercostal cryoanalgesia from T3 to T7, billateral
Thoracic epidural block
Length of stay (LOS)
Length of stay (LOS) is measured in days from postoperative day (POD) 0 until discharge from hospital.
Time frame: Perioperative/Periprocedural.
Numeric pain scale
From 0 to 10
Time frame: Perioperative/Periprocedural
Opioid use
Oral Morphine Equivalents (OME)
Time frame: Perioperative/Periprocedural
Postoperative complications
Surgical complications are registered through an specific scale.
Time frame: 30 days post-surgery.
Readmissions to the emergency room or hospital readmission
Compare the frequency and reason for readmissions to the emergency room or hospital admission between groups.
Time frame: Within 30 days after surgery
Frequency of neuropathic pain
Incidence of chronic neuropathic pain and paresthesia up to 1 year post-surgery in the group undergoing intercostal cryoablation, using LANNS (Leeds assessment of Neuropathic Symptoms and Signs) scale.
Time frame: Up to 1 year post-surgery.
Satisfaction with the post-operative result
Compare patient-reported experience measures (PREMs) between the intercostal cryoablation and thoracic epidural block groups based on postoperative satisfaction at 6 months, assessed using the Single Step Questionnaire (SSQ) score.
Time frame: Single evaluation during the outpatient follow-up 6 months after surgery.
Cost of hospitalization (in Brazilian Real)
Compare the total cost of hospitalization during the hospital stay between the two groups.
Time frame: Perioperative/Periprocedural
PDFs hosted by the registry, ClinicalTrials.gov.
Started Nov 2024 (actual). Primary completion is estimated for Jan 2027, 26 months after the start.
Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 26 months is below that.
How these figures are worked out, and which studies are left out of them.
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