Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT06657092
Status:
COMPLETED
Last Update Posted:
2024-10-28
First Post:
2023-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Erector Spinae Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001941', 'term': 'Breast Diseases'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were randomized into two groups, ESPB and control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total opioid consumption', 'timeFrame': 'Postoperative total opioid consumption in miligrams will be recorded at hour 24', 'description': 'Patients in both groups will receive opioid in postoperative period. Total opioid consumption in miligrams will be compared'}], 'secondaryOutcomes': [{'measure': 'Intraoperative opioid consumption', 'timeFrame': 'At the end of the operation', 'description': 'The amount of remifentanyl administered to patients via intravenous infusion during the operation in micrograms, will be recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Diseases']}, 'descriptionModule': {'briefSummary': 'Patients were randomized into two groups, ESP and control. Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level was performed preoperatively to all patients in the ESP group. The control group received no intervention. Patients in both groups were provided with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-65 age\n2. Patients who scheduled for bilateral reduction mammoplasty\n3. ASA Class I-II\n\nExclusion Criteria:\n\n1\\. Coagulopaty'}, 'identificationModule': {'nctId': 'NCT06657092', 'briefTitle': 'Ultrasound Guided Erector Spinae Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Ultrasound Guided Erector Spinae Plane Efficacy of Erector Spinae Plane Block for Analgesia in Breast Surgery', 'orgStudyIdInfo': {'id': 'Kocaeli Univercity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'erector spinae plane block group', 'description': 'Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level', 'interventionNames': ['Procedure: Erector Spinae Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'morphine pca to patient', 'interventionNames': ['Procedure: Standart therapy']}], 'interventions': [{'name': 'Erector Spinae Plane Block', 'type': 'PROCEDURE', 'otherNames': ['espb group'], 'description': 'Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine ( Marcaine ) at the T4 vertebral level will be performed.', 'armGroupLabels': ['erector spinae plane block group']}, {'name': 'Standart therapy', 'type': 'PROCEDURE', 'description': 'Postoperative 0.5 mg/kg morphine and 1 gr paracetamol will be admistered intravenously in the operation theatre and intravenous patient controlled analgesia (PCA) will be performed in the plastic surgery ward postoperatively', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Kocaeli', 'state': 'izmit', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli Unıversity', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gözde Gamze Uzun', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant Anesthesiologist', 'investigatorFullName': 'Gözde Gamze Uzun', 'investigatorAffiliation': 'Kocaeli University'}}}}