Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 6:34 PM
Study NCT ID:
NCT03744520
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensorial Block Assessment of Erector Spinae Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2018-10-25', 'studyFirstSubmitQcDate': '2018-11-14', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spread of sensorial block', 'timeFrame': 'in postoperative sixth hours', 'description': 'The sensorial block will be evaluated with dermatomal examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['regional anesthesia'], 'conditions': ['Regional Anesthesia Morbidity']}, 'descriptionModule': {'briefSummary': 'Ultrasound-guided erector spinae plane blocks are used as postoperative analgesia method for abdominal, chest and hip surgeries. Regional techniques are well-described methods for postoperative analgesia. However, the sensorial dermatomal spread of regional block varies depending on the multiple variables as the level of the block, local analgesic concentration etc. The aim of this study is to observe dermatomal evaluation of sensorial block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients who received successful erector spinae plane block for postoperative analgesia\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients who are not able to communicate with\n* Patients who are on medication which may change the perception of pain.'}, 'identificationModule': {'nctId': 'NCT03744520', 'briefTitle': 'Sensorial Block Assessment of Erector Spinae Block', 'organization': {'class': 'OTHER', 'fullName': 'Maltepe University'}, 'officialTitle': 'Assessment of Dermatomal Sensorial Block of Erector Spinae Plane Block: Randomized, Prospective, Study', 'orgStudyIdInfo': {'id': 'Sensorial Block assessment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESP block group', 'description': 'The patients who had paravertebral interfacial plane block for postoperative analgesia', 'interventionNames': ['Procedure: Erector spinae plane block']}], 'interventions': [{'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Local anesthetic infiltration is applied between the erector spinae muscle fascia and transverse process.', 'armGroupLabels': ['ESP block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34843', 'city': 'Istanbul', 'state': 'Maltepe', 'country': 'Turkey (Türkiye)', 'facility': 'Maltepe University Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Onur Selvi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Onur Selvi', 'investigatorAffiliation': 'Maltepe University'}}}}