Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-21 @ 7:52 PM
Study NCT ID:
NCT03480958
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2018-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2018-03-18', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': '24 hour postoperatively', 'description': 'All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Numering Rating Scale scores for pain', 'timeFrame': '24 hour', 'description': 'Numeric Rating Scale (NRS) for pain will be used. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 means no pain and 10 means most imaginable pain'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': '24h', 'description': 'Incidence of postoperative nausea and vomiting will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erector spinae plane block', 'thoracic paravertebral block', 'breast surgery', 'postoperative pain'], 'conditions': ['Postoperative Pain', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '31280100', 'type': 'DERIVED', 'citation': 'Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of this study is to compare the analgesic effect of ultrasound guided ESB with thoracic paravertebral block - the golden standard method for postoperative regional analgesia technique in breast surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25-70 years of agge\n* ASA I-II\n* Undergoing elective breast cancer surgery\n\nExclusion Criteria:\n\n* obesity (body mass index \\>35 kg/m2)\n* infection of the skin at the site of needle puncture area\n* patients with known allergies to any of the study drugs\n* coagulopathy\n* recent use of analgesic drugs'}, 'identificationModule': {'nctId': 'NCT03480958', 'briefTitle': 'Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery', 'orgStudyIdInfo': {'id': '2018-94'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ESP group', 'description': 'Erector Spinae Plane Block administered group', 'interventionNames': ['Device: Intravenous morphine patient controlled device', 'Other: Erector Spinae Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TPVB group', 'description': 'Thoracic Paravertebral Block administered group', 'interventionNames': ['Device: Intravenous morphine patient controlled device', 'Other: Thoracic Paravertebral Block']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'No regional anesthesia technique will be applied to control group; but will be provided with iv PCA', 'interventionNames': ['Device: Intravenous morphine patient controlled device']}], 'interventions': [{'name': 'Intravenous morphine patient controlled device', 'type': 'DEVICE', 'description': '24 hour morphine consumption will be recorded', 'armGroupLabels': ['Control Group', 'ESP group', 'TPVB group']}, {'name': 'Erector Spinae Plane Block', 'type': 'OTHER', 'description': 'erector spinae plane block will be administered before the surgery', 'armGroupLabels': ['ESP group']}, {'name': 'Thoracic Paravertebral Block', 'type': 'OTHER', 'description': 'thoracic paravertebral block will be administered before the surgery', 'armGroupLabels': ['TPVB group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41340', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yavuz Gurkan', 'investigatorAffiliation': 'Kocaeli University'}}}}