Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04449367
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2020-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ERECTOR SPINAE BLOCK AFTER THORACIC SPINE SURGERY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-26', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ultrasound guided erector spinae plane block can be used for postoperative analgesia for patients undergoing thoracic spine sugery', 'timeFrame': '2 days', 'description': 'postoperative analgesia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Analgesia']}, 'descriptionModule': {'briefSummary': 'the effectiveness of ultrasound guided erector spinae plane block in patients undergoing thoracic spine sugery', 'detailedDescription': 'bilateral erector spinae plane block would be given to patients with thoracic spine sugery for postoperative analgesia \\& its effectiveness would be evaluated for 2 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients underging thoracic spine sugery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postoperative thoracic spine sugery\n\nExclusion Criteria:\n\n* less then 18 years\n* more than 65 years'}, 'identificationModule': {'nctId': 'NCT04449367', 'acronym': 'SPINE', 'briefTitle': 'ERECTOR SPINAE BLOCK AFTER THORACIC SPINE SURGERY', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dubai Health Authority'}, 'officialTitle': 'THE EFFECTIVENESS OF AN ULTRASOUND GUIDED RECTOR SPINAE BLOCK IN PATIENTS UNDERGOING THORACIC SPINE SURGERY', 'orgStudyIdInfo': {'id': 'DSREC-04/2018_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Randomized and Single-Arm Trials', 'description': 'a sham comparator (no intervention)', 'interventionNames': ['Procedure: ultrasound guided erector spinae plane block']}], 'interventions': [{'name': 'ultrasound guided erector spinae plane block', 'type': 'PROCEDURE', 'description': 'bilatral block given to patients under general anaesthesia for thoracic spine sugery to contorl post operative pain', 'armGroupLabels': ['Randomized and Single-Arm Trials']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Dubai Health Authority', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dubai Health Authority', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'SPECIALIST ANAESTHESIOLOGIST', 'investigatorFullName': 'Dr Manar Mamdouh Fahmy Elsharkawi', 'investigatorAffiliation': 'Dubai Health Authority'}}}}