Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT07137702
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2025-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Erector Spinae Plane Block on Systemic Immune-inflammation Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-16', 'studyFirstSubmitDate': '2025-08-16', 'studyFirstSubmitQcDate': '2025-08-16', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'systemic immune-inflammation index', 'timeFrame': '7 days after surgery', 'description': 'Platelet count × Neutrophil count / Lymphocyte count'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['systemic immune-inflammatory index', 'erector spinae plane block', 'breast conserving surgery'], 'conditions': ['Systemic Immune-inflammatory Index', 'Erector Spinae Plane Block', 'Breast Conserving Surgery']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine whether there is a relationship between postoperative SII and erector spinae plane block application. If data emerges indicating a more suppressed inflammatory response in patients undergoing block, widespread use of this block in the specified patient group would reflect the clinical significance of the study.\n\nThe searches did not uncover any studies investigating the effects of trunk blocks, such as erector spinae plane block, on postoperative systemic inflammatory response, indicating that this study could make a significant contribution to the literature.', 'detailedDescription': 'Because the study will be conducted retrospectively, it carries no potential risks.\n\nIf it can be demonstrated that blocking has a suppressive effect on the inflammatory response, the main expected benefit of the study is its widespread use to improve postoperative outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women who have undergone breast-conserving surgery for malignant causes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: ASA score ≤ 3, breast-conversing surgery, age \\> 18 -\n\nExclusion Criteria: ASA score \\> 3, reoperation, surgical wound infection, chemotherapy in less than 2 weeks, bening lesions\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07137702', 'briefTitle': 'Impact of Erector Spinae Plane Block on Systemic Immune-inflammation Index', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Saglik Bilimleri University'}, 'officialTitle': 'Impact of Erector Spinae Plane Block on Systemic Immune-inflammation Index in Breast-conserving Surgery: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '2025-225'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ESPB + group', 'description': 'the patients who received erector spinae plane block', 'interventionNames': ['Procedure: Erector Spinae Plane Block']}, {'label': 'ESPB - group', 'description': "the patients who didn't receive erector spinae plane block"}], 'interventions': [{'name': 'Erector Spinae Plane Block', 'type': 'PROCEDURE', 'description': 'A standardized perioperative care management protocol is applied for all breast-conserving surgery procedures in our department. All patients are informed about ESPB and offered its application preoperatively. Patients who accept the procedure receive ESPB (preoperatively, in the sitting position, at the level of ipsilateral T4 vertebra, USG guided, out-of-plane approach) while those who refuse are subjected to routine intravenous analgesia protocols. All blocks were performed by an anesthesiologist experienced in the application of truncal blocks and 20 cc 0.5% bupivacaine (within the safe dose range for all patients to be used according to their weight) are injected and its spread is visualized under USG.', 'armGroupLabels': ['ESPB + group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Basaksehir Cam ve Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taner Abdullah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Taner Abdullah', 'investigatorAffiliation': 'Istanbul Saglik Bilimleri University'}}}}