Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-01-07 @ 5:14 PM
Study NCT ID:
NCT03650868
Status:
COMPLETED
Last Update Posted:
2019-02-28
First Post:
2018-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049291', 'term': 'Seroma'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, 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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-27', 'studyFirstSubmitDate': '2018-08-27', 'studyFirstSubmitQcDate': '2018-08-28', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroma quantitiy', 'timeFrame': '24 hour postoperatively.', 'description': 'Seroma quantitiy of all patients will be recorded after 24 hour postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracal Paravertebral Block', 'Breast Surgery', 'Seroma Reduction'], 'conditions': ['Seroma', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Thoracal paravertebral block (TPVB) is a commonly prefferred regional anesthesia technique to provide postoperative analgesia. In addition, the successful use of TPVB is reported for some seroma related pain cases. Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast and in addition to this complex mechanisms, seroma accumulation has a negative effect for patients postoperatively. With this study, the investigators aimed to study the effect of TPVB on seroma reduction for breast cancer surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-70 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'}, 'identificationModule': {'nctId': 'NCT03650868', 'briefTitle': 'The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery, a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'KIA 2018/155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No intervention will be applied to control group'}, {'type': 'EXPERIMENTAL', 'label': 'TPVB group', 'description': 'Thoracal paravertebral block will be performed with 20cc of 0,25% bupivacaine preoperatively.', 'interventionNames': ['Procedure: Thoracal paravertebral block']}], 'interventions': [{'name': 'Thoracal paravertebral block', 'type': 'PROCEDURE', 'description': 'Thoracal paravertebral block will be performed before the surgery to the TPVB group.', 'armGroupLabels': ['TPVB group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Alparslan Kus', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kocaeli Üniversitesi Tıp Fakültesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Alparslan Kus', 'investigatorAffiliation': 'Kocaeli University'}}}}