Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT07200960
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2025-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of Erector Spinae Plane Block Versus Retrolaminar Block in Patients Undergoing Major Oncological Breast Surgery: an RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'will be asked regarding the group of blocks being employed.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of pain score of patients receiving ESPB and retrolaminar block', 'timeFrame': '2hours post surgery', 'description': 'NRS score'}], 'secondaryOutcomes': [{'measure': 'Comparison of total opioid consumption in 24 hours of patients receiving ESPB and retrolaminar block', 'timeFrame': '24 hours post surgery', 'description': 'total consumption of opioids in MG'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Managment & Opioid Consumption']}, 'descriptionModule': {'briefSummary': 'The study aims to compare the efficacy in pain control and total opioid consumption after the use of ESPB and retrolaminar block in patients undergoing major oncological breast surgery..', 'detailedDescription': 'The study aims to compare the efficacy in pain control and total opioid consumption after the use of ESPB and retrolaminar block in patients undergoing major oncological breast surgery..'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female population has a bigger incision as compared to male population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients between 18- 60 years ASA 1 and 2\n\nExclusion Criteria:\n\n* Patient refusal Allergic reaction infection emergency case BMI \\>35'}, 'identificationModule': {'nctId': 'NCT07200960', 'briefTitle': 'Analgesic Efficacy of Erector Spinae Plane Block Versus Retrolaminar Block in Patients Undergoing Major Oncological Breast Surgery: an RCT', 'organization': {'class': 'OTHER', 'fullName': 'Shaukat Khanum Memorial Cancer Hospital & Research Centre'}, 'officialTitle': 'Analgesic Efficacy of Erector Spinae Plane Block Versus Retrolaminar Block in Patients Undergoing Major Oncological Breast Surgery: a Randomized Controllled Trial', 'orgStudyIdInfo': {'id': 'IRB-23-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient receiving ESPB for major oncological breast surgery', 'description': 'Patient receiving ESPB for major oncological breast surgery', 'interventionNames': ['Procedure: ESPB']}, {'type': 'EXPERIMENTAL', 'label': 'Patient receiving Retrolaminar block for major oncological breast surgery', 'description': 'Patient receiving ESPB for major oncological breast surgery', 'interventionNames': ['Procedure: ESPB']}], 'interventions': [{'name': 'ESPB', 'type': 'PROCEDURE', 'otherNames': ['Retrolaminar Block'], 'description': 'Patient receiving ESPB for major oncological breast surgery Patient receiving Retrolaminar Block for major oncological breast surgery', 'armGroupLabels': ['Patient receiving ESPB for major oncological breast surgery', 'Patient receiving Retrolaminar block for major oncological breast surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Shaukat Khanum Memorial Cancer Hospital & Research Centre.', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaukat Khanum Memorial Cancer Hospital & Research Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}