Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-25 @ 11:46 PM
Study NCT ID:
NCT01903551
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2013-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Loco-regional Analgesia for Post-operative Pain Management in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2013-07-13', 'studyFirstSubmitQcDate': '2013-07-18', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU lenght of stay and hospital stay', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Mechanical ventilation in the post-operative period', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['post-operative pain', 'loco-regional analgesia', 'minimally invasive surgery'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate whether loco-regional analgesia reduces post operative pain compared to intravenous analgesia, in patients undergoing cardiac surgery in minithoracotomy. All patients will be randomized to receive locoregional analgesia (treatment group) or intravenous analgesia (control group), at the end of the cardiac intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing minithoracotomy for cardiac surgery, \\> 18 years old\n\nExclusion Criteria:\n\n* psychiatric diseases, which might limit pain evaluation; urgent surgery; patients on ECMO; lack of consent'}, 'identificationModule': {'nctId': 'NCT01903551', 'briefTitle': 'Loco-regional Analgesia for Post-operative Pain Management in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Phase 3 Study of Post-operative Pain Management With Loco-regional Analgesia in Minithoracotomy for Cardiac Surgery. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UTurin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Loco-regional catheter', 'description': 'A suprafascial catheter will be positioned at the end of cardiac intervention during the thoracotomy closure. The catheter will be connected to a elastomeric pump, which delivers the analgesic drug (ropivacaine).', 'interventionNames': ['Device: Loco-regional catheter']}, {'type': 'NO_INTERVENTION', 'label': 'Intravenous analgesia', 'description': 'At the end of the cardiac intervention each patient will receive intravenous analgesia with morphine at 0.8 mg/h.'}], 'interventions': [{'name': 'Loco-regional catheter', 'type': 'DEVICE', 'description': 'it is an intra-fascial catheter for realing of the drug locally', 'armGroupLabels': ['Loco-regional catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'state': 'Italy', 'country': 'Italy', 'facility': 'Cardiac Intensive Care Unit', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Daniela Pasero', 'investigatorAffiliation': 'University of Turin, Italy'}}}}