Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-06 @ 1:52 PM
Study NCT ID:
NCT07431632
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Cryoanalgesia Versus Thoracic Epidural Block in MIRPE (Minimally Invasive Repair of Pectus Excavatum)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005660', 'term': 'Funnel Chest'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D007268', 'term': 'Injections, Epidural'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-23', 'size': 413202, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-18T13:56', 'hasProtocol': True}, {'date': '2024-03-08', 'size': 324224, 'label': 'Informed Consent Form: Informed consent form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-18T14:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay (LOS)', 'timeFrame': 'Perioperative/Periprocedural.', 'description': 'Length of stay (LOS) is measured in days from postoperative day (POD) 0 until discharge from hospital.'}], 'secondaryOutcomes': [{'measure': 'Numeric pain scale', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'From 0 to 10'}, {'measure': 'Opioid use', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Oral Morphine Equivalents (OME)'}, {'measure': 'Postoperative complications', 'timeFrame': '30 days post-surgery.', 'description': 'Surgical complications are registered through an specific scale.'}, {'measure': 'Readmissions to the emergency room or hospital readmission', 'timeFrame': 'Within 30 days after surgery', 'description': 'Compare the frequency and reason for readmissions to the emergency room or hospital admission between groups.'}, {'measure': 'Frequency of neuropathic pain', 'timeFrame': 'Up to 1 year post-surgery.', 'description': '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.'}, {'measure': 'Satisfaction with the post-operative result', 'timeFrame': 'Single evaluation during the outpatient follow-up 6 months after surgery.', 'description': '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.'}, {'measure': 'Cost of hospitalization (in Brazilian Real)', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Compare the total cost of hospitalization during the hospital stay between the two groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cryoanalgesia', 'pectus excavatum', 'funnel chest', 'postoperative pain', 'MIRPE'], 'conditions': ['Funnel Chest', 'Pectus Excavatum', 'Postoperative Pain After Video Assisted Thoracic Surgery', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Having pectus excavatum;\n2. Having signed the Informed Consent Form for the study.\n\nExclusion Criteria:\n\n1. Age \\< 13 years at the time of the procedure;\n2. Chronic use of analgesics preoperatively;\n3. Pectus carinatum, Poland syndrome, or other chest wall anomalies;\n4. Previous pectus excavatum repair by any technique;\n5. Previous thoracic surgery;\n6. Congenital heart disease;\n7. Hemorrhagic dyscrasia;\n8. Major anesthetic risk factors or history of previous problems with anesthesia;\n9. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT07431632', 'acronym': 'FROZEN MIRPE', 'briefTitle': 'Intraoperative Cryoanalgesia Versus Thoracic Epidural Block in MIRPE (Minimally Invasive Repair of Pectus Excavatum)', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Comparative Study of the Efficacy of Intraoperative Intercostal Cryoanalgesia and Thoracic Epidural Block in the Postoperative Period of Minimally Invasive Pectus Excavatum Repair (MIRPE): a Prospective, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '83154924.6.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraoperative intercostal cryoanalgesia', 'description': 'Intercostal nerve cryoanalgesia with the Cryo-S Painless device from Metrum Cryoflex', 'interventionNames': ['Device: Cryotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracic epidural block', 'description': 'Thoracic epidural block', 'interventionNames': ['Procedure: Epidural']}], 'interventions': [{'name': 'Cryotherapy', 'type': 'DEVICE', 'description': 'Intraoperative intercostal cryoanalgesia from T3 to T7, billateral', 'armGroupLabels': ['Intraoperative intercostal cryoanalgesia']}, {'name': 'Epidural', 'type': 'PROCEDURE', 'description': 'Thoracic epidural block', 'armGroupLabels': ['Thoracic epidural block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403904', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Diego Arley G Silva, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Miguel L Tedde, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paulo Manuel Pego-Fernandes, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Thoracic Surgery Division, Heart Institute (InCor), University of Sao Paulo Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Miguel L Tedde, MD, PhD', 'role': 'CONTACT', 'email': 'tedde@usp.br', 'phone': '55-11-99653-5030'}, {'name': 'Diego Arley G Silva, MD', 'role': 'CONTACT', 'email': 'diegoarley@usp.br', 'phone': '55-83-98650-6438'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Miguel L. Tedde', 'investigatorAffiliation': 'University of Sao Paulo'}}}}