Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT04989933
Status:
UNKNOWN
Last Update Posted:
2021-08-04
First Post:
2021-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-31', 'studyFirstSubmitDate': '2021-07-31', 'studyFirstSubmitQcDate': '2021-07-31', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rescue analgesia', 'timeFrame': 'Post-extubation 24 hours', 'description': 'Total amount of rescue analgesic'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sternotomy Pain']}, 'descriptionModule': {'briefSummary': 'The erector spine plane block is currently used in many surgeries to provide postoperative analgesia. It has also been used successfully in open-heart surgery for postoperative sternotomy pain. However, an ideal volume that will provide optimum analgesia has not yet been determined.\n\nThis study aims to compare the effects of ESP block administered in two different volumes on poststernotomy pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery\n\nExclusion Criteria:\n\n* chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases"}, 'identificationModule': {'nctId': 'NCT04989933', 'acronym': 'ESP', 'briefTitle': 'Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Ultrasound Guided Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery: Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'AtaturkU-AnkaraCH'}, 'secondaryIdInfos': [{'id': 'Asli Demir', 'type': 'OTHER', 'domain': 'Ankara City Hospital'}, {'id': 'Ali Ahiskalioglu', 'type': 'OTHER', 'domain': 'Ataturk University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESP 20 ml', 'description': 'Ultrasound-Guided erector spinae plane block with 20 ml of 0.25% bupivacaine', 'interventionNames': ['Procedure: Ultrasound-guided erector spinae plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ESP 30 ml', 'description': 'Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine', 'interventionNames': ['Procedure: Ultrasound-guided erector spinae plane block']}], 'interventions': [{'name': 'Ultrasound-guided erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Ultrasound-Guided erector spinae plane block with 0.25% bupivacaine', 'armGroupLabels': ['ESP 20 ml', 'ESP 30 ml']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Ali Ahiskalioglu', 'investigatorAffiliation': 'Ataturk University'}}}}