Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT05201820
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2021-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cryoanalgesia for Pain Management After Pectus Excavatum Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005660', 'term': 'Funnel Chest'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2022-01-09', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life by PedsQL 23 items', 'timeFrame': 'Two weeks after surgery', 'description': 'Quality of life after surgery'}], 'secondaryOutcomes': [{'measure': 'YAPFAQ (Youth Acute Pain Functional Ability Questionnaire)', 'timeFrame': 'One week after surgery', 'description': 'A scale for assessment of activity limitations in children and adolescents. Range fro 0 to 100'}, {'measure': 'Pain by VAS', 'timeFrame': '1-14 days after surgery', 'description': 'Numeric pain score 0-10'}, {'measure': 'Thoracic hypo-aesthesia', 'timeFrame': 'Six months after surgery', 'description': 'Cold test assessment (Yes/No)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pectus Excavatum']}, 'referencesModule': {'references': [{'pmid': '33853733', 'type': 'BACKGROUND', 'citation': 'Arshad SA, Hatton GE, Ferguson DM, Li LT, Austin MT, Tsao K; PAPS SPONSOR. Cryoanalgesia enhances recovery from minimally invasive repair of pectus excavatum resulting in reduced length of stay: A case-matched analysis of NSQIP-Pediatric patients. J Pediatr Surg. 2021 Jul;56(7):1099-1102. doi: 10.1016/j.jpedsurg.2021.03.017. Epub 2021 Mar 24.'}, {'pmid': '40035332', 'type': 'DERIVED', 'citation': 'Bastianello M, Torre M, Bonfiglio R, Calevo MG, Palomba L, Uva P, Kanapari A, Lorenzoni G, Disma N; COPPER consortium. Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) in Adolescents: A Randomized Controlled Trial. Paediatr Anaesth. 2025 May;35(5):347-358. doi: 10.1111/pan.15090. Epub 2025 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'Cryoanalgesia for pain management after pectus excavatum repair. COPPER study (CryoanalgesiafOr Pain management after Pectus Excavatum Repair): a randomized controlled trial.\n\nDetermine if, in patients more than 12 years of age having cryoanalgesia for pectus excavatum repair analgesia improves the standard of care (epidural analgesia) in term of pain relief and return to normal life 2 weeks after surgery.\n\nRandomized active controlled, parallel group, single-centre, trial (category IIb medical device).\n\n88 patients aged more than 12 years of age scheduled for pectus excavatum repair. After randomization, patients will receive intraoperative cryo-analgesia or standard of care (epidural-analgesia).\n\nPedsQLscale (23 items) two weeks after surgery.\n\nPatients will be followed for 6 months after surgery to determine time until return to normal life and occurrence of any complication related to the use of cryo-analgesia. Numeric Rating Scale (NRS), CALI9, YAPFAQ will be measured at fixed times to determine pain intensity and limitations due to pain. Risk factors for prolonged pain and time needed until achieving discharge criteria from hospital will be reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing pectus excavatum repair with NUSS technique\n* aged 12 years or above12\n* informed consent signed for cryoanalgesia\n\nExclusion Criteria:\n\n\\- Age of 11 years or below\n\n* Refuse to receive cryoanalgesia or epidural catheter as primary pain relief\n* Any contraindication to cryoanalgesia\n* Difficult follow-up for geographical reasons and/or impossibility by the patient to understand how to perform self-measurements'}, 'identificationModule': {'nctId': 'NCT05201820', 'acronym': 'COPPER', 'briefTitle': 'Cryoanalgesia for Pain Management After Pectus Excavatum Repair', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Giannina Gaslini'}, 'officialTitle': 'Cryoanalgesia for Pain Management After Pectus Excavatum Repair. COPPER Study (CryoanalgesiafOr Pain Management After Pectus Excavatum Repair): a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'COPPER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Epidural analgesia'}, {'type': 'EXPERIMENTAL', 'label': 'Cryoanalgesia', 'description': 'Cryoanalgesia', 'interventionNames': ['Device: Cryoanalgesia']}], 'interventions': [{'name': 'Cryoanalgesia', 'type': 'DEVICE', 'description': 'Cryoanalgesia will be applied during surgery on 6 intercostal nerves each side', 'armGroupLabels': ['Cryoanalgesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Genova', 'country': 'Italy', 'facility': 'Istituto Giannina Gaslini', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'At the time of submission for publication', 'ipdSharing': 'YES', 'description': 'Once final publication is accepted, other researchers can request IPD', 'accessCriteria': 'By request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Giannina Gaslini', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Research and Innovation Unit', 'investigatorFullName': 'Nicola Disma, MD', 'investigatorAffiliation': 'Istituto Giannina Gaslini'}}}}