Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-31 @ 6:39 PM
Study NCT ID:
NCT06935006
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2025-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Block vs Conventional Analgesia for Postoperative Analgesia in PCNL
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', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-03-09', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of postoperative pain', 'timeFrame': '1 year', 'description': 'VAS score for pain measurement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Percutaneous Nephrolithotomy (PCNL)']}, 'descriptionModule': {'briefSummary': '50 adult patients scheduled for percutaneous nephrolithotomy in Sohag university hospitals will be devided in two groups one of them will receive Sonographic guided erector spinae plane block using 20 ml volume of bupivacaine 0.25 percent and the other will receive conventional analgesia of 0.1 mg/kg IV morphine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1 to ASA 2 18 to 60 years\n\nExclusion Criteria:\n\n* patient refusal Significant neurological , psychiatric or neuromascular disease Drug abuse Pregnant or lactating women Suspected coagulopathy Morbid obesity Known allergy to some medications Septicaemia and local infection at block site'}, 'identificationModule': {'nctId': 'NCT06935006', 'briefTitle': 'Erector Spinae Block vs Conventional Analgesia for Postoperative Analgesia in PCNL', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Sonographic Guided Erector Spinae Plane Block Versus Conventional Analgesia After Percutaneous Nephrolithotomy a Comparative Randomized Study', 'orgStudyIdInfo': {'id': 'Soh-Med-22-06-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spinae plane block group', 'interventionNames': ['Procedure: Sonographic guided Erector spinae plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional analgesia group', 'interventionNames': ['Drug: Intravenous opioid']}], 'interventions': [{'name': 'Sonographic guided Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Ultrasound guided plane block using 20 ml of 0.25% bupivacaine at the level of transverse process of T8', 'armGroupLabels': ['Erector spinae plane block group']}, {'name': 'Intravenous opioid', 'type': 'DRUG', 'description': '0.1 mg/kg morphine intravenous pre operative', 'armGroupLabels': ['Conventional analgesia group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Mahmoud Azmy, Assistant lecturer', 'role': 'CONTACT', 'email': 'ahmedazmy19692@yahoo.com', 'phone': '01004793896'}, {'name': 'Fawzy Abbas, Assistant professor', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of Anaethesia and intensive care unit', 'investigatorFullName': 'Ahmed Mahmoud Azmy', 'investigatorAffiliation': 'Sohag University'}}}}