Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT01989351
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2013-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predisposition to Persistent Pain After Orthopaedic Surgery: Genetic Aspects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2013-11-05', 'studyFirstSubmitQcDate': '2013-11-14', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of SNPs rs12654788 and rs1042713 of ADBR2 gene in patients who complain persistent pain 4 months postoperatively compared to chronic pain free patients.', 'timeFrame': '4 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Expression frequency of OPRM1, COMT, IL1Ra', 'timeFrame': '6, 12, 24, 48 hours'}, {'measure': 'Serum concentration of TNFα, TGFβ, IFNγ, IL-6 and IL-10 obtained with ELISA system', 'timeFrame': '6, 12, 24 and 48 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The study purpose is to examine polymorphism of genes associated to post-operative persistent pain and to verify the possible association between genotype phenotype and ADRB2 polymorphism in orthopaedic surgery. The primary aim is to evaluate the expression of ADBR2 in VAS\\>4 patients and to compare it to those with VAS\\<4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing total knee arthoplasty.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18\n* ASA I to III\n\nExclusion Criteria:\n\n* Contraindications to regional anesthesia procedures\n* Not stabilized neurological diseases\n* Diabetes'}, 'identificationModule': {'nctId': 'NCT01989351', 'briefTitle': 'Predisposition to Persistent Pain After Orthopaedic Surgery: Genetic Aspects', 'organization': {'class': 'OTHER', 'fullName': 'ASST Gaetano Pini-CTO'}, 'officialTitle': 'LA PREDISPOSIZIONE AL DOLORE PERSISTENTE POST OPERATORIO IN AMBITO ORTOPEDICO: ASPETTI GENETICI', 'orgStudyIdInfo': {'id': 'IOGPGC03-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VAS<4'}, {'label': 'VAS>4'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Ortopedico G. Pini', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Gianluca Cappelleri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASST Gaetano Pini-CTO'}, {'name': 'Manuela de Gregori, Biologist', 'role': 'STUDY_CHAIR', 'affiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, {'name': 'Massimo Allegri, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ASST Gaetano Pini-CTO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Gianluca Cappelleri', 'investigatorAffiliation': 'ASST Gaetano Pini-CTO'}}}}