Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-03-29 @ 5:55 AM
Study NCT ID:
NCT03862404
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2019-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinded drug preparation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'RCT with one active group and a control (placebo) group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-04', 'studyFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2019-03-04', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in VAS scores', 'timeFrame': 'from 0 hour to 24 hour', 'description': 'ISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours'}], 'secondaryOutcomes': [{'measure': 'Forced Vital Capacity', 'timeFrame': 'from 0 hour to 48 hour'}, {'measure': 'Total epidural infusion', 'timeFrame': 'from 0 hour to 48 hour'}, {'measure': 'Co-analgesia consumption', 'timeFrame': 'from 0 hour to 48 hour'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Thoracic Surgery']}, 'descriptionModule': {'briefSummary': 'While thoracic epidural could control incisional pain after thoracotomy, an excruciating ipsilateral shoulder pain happens post thoracotomy and could affect up to 85% of thoracotomy patients. It is often difficult to manage and relatively resistant to opioids. The investigators postulate that in the presence of a functioning thoracic epidural, intrapleural bupivacaine administered through the chest tube could be effective in reducing post thoracotomy ipsilateral shoulder pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female, between 18 and 80 years, ASA 1-3, Scheduled for open thoracotomy\n\nExclusion Criteria:\n\n* ASA \\>3, morbid obesity BMI\\>40, Previous cardiac or ipsilateral thoracic surgery, Renal or hepatic failure, anemia, allergy to local anesthetics, contraindications to receive regional anesthesia, patient refusal, reiteration due to complication'}, 'identificationModule': {'nctId': 'NCT03862404', 'briefTitle': 'Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Double-blind Comparison of Intrapleural Bupivacaine and Saline for Ipsilateral Shoulder Pain After Thoracotomy in Patients Receiving Thoracic Epidural Analgesia', 'orgStudyIdInfo': {'id': '2017-3277'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Patients in this group receive Normal Saline injection in the inter pleural space', 'interventionNames': ['Drug: Normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Patients in this group receive Bupivacaine 0.25% + Epinephrine 5 mcg/ml injection in the inter pleural space', 'interventionNames': ['Drug: Bupivacaine-epinephrine']}], 'interventions': [{'name': 'Bupivacaine-epinephrine', 'type': 'DRUG', 'description': 'See previous description', 'armGroupLabels': ['Experimental group']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'See previous descreption', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia', 'investigatorFullName': 'JF Asenjo', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}