Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT05813834
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2023-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Genicular Nerves Block
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', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Genicular Nerves Block'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2023-04-03', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post operative VAS', 'timeFrame': '24 hours', 'description': 'vas score'}], 'secondaryOutcomes': [{'measure': 'total morphine consumption', 'timeFrame': '24 hours', 'description': 'morphine onsumpton'}, {'measure': 'time to first morphine analgesia', 'timeFrame': '24 hours', 'description': 'rescue analgesia'}, {'measure': 'range of motion', 'timeFrame': '24 hours', 'description': 'rom'}, {'measure': 'post operative MAP', 'timeFrame': '24 hours', 'description': 'map'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Genicular Nerve Block for Pain in ACL Arthroscopy']}, 'descriptionModule': {'briefSummary': "Most of arthroscopic ACL repairs are day case surgeries associated with moderate postoperative pain and discomfort. So , finding an effective and safe, analgesic technique with minimal complications is our goal for fast recovery and short hospital stay.\n\nin this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.", 'detailedDescription': "In this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both genders\n* age 18 - 65\n* ASA i, ii, iii\n\nExclusion Criteria:\n\n* ROM less than 90\n* advanced renal or liver diseases\n* patient refusal\n* substance abuse\n* site infection\n* known sensitivity to any of study drugs'}, 'identificationModule': {'nctId': 'NCT05813834', 'briefTitle': 'Ultrasound-guided Genicular Nerves Block', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'US-guided Genicular Nerves Block for Pain Control After Arthroscopic Anterior Cruciate Ligament Repair: A Prospective, Double Blinded, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'MS-502-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'genicular nerve block group', 'description': 'patients will receive genicular nerves block', 'interventionNames': ['Procedure: Genicular Nerves Block']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'patients will not receive genicular nerves block'}], 'interventions': [{'name': 'Genicular Nerves Block', 'type': 'PROCEDURE', 'description': 'US guided genicular nerves block', 'armGroupLabels': ['genicular nerve block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'faculty of medicine Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dalia K Ismail', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesia, Surgical ICU and pain management at Faculty of medicine Cairo University', 'investigatorFullName': 'Dalia Ismail', 'investigatorAffiliation': 'Cairo University'}}}}