Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-01 @ 6:42 AM
Study NCT ID:
NCT07058493
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2024-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine as an Additive for (Ipack)Block in Knee Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2024-05-05', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale at rest score during first postoperative 48 hours', 'timeFrame': '48 postoperative hours', 'description': 'Visual Analog Scale at rest during first postoperative 48 hours a line 10centimeters long from zero to10 where 10 is the worst pain ever'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale at rest and during movement at 30 minuts, 2, 8, 16, 24, 36, and 48 hours', 'timeFrame': '48 postoperative hours', 'description': 'Visual Analog Scale at rest during 48 postoperative hour a line 10centimeters long from zero to10 where 10 is the worst pain ever'}, {'measure': 'Duration of the block', 'timeFrame': '48 hours', 'description': 'Duration of the block'}, {'measure': 'Heart Rate', 'timeFrame': '48 hours', 'description': 'Heart Rate'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': '48 hours', 'description': 'Mean Arterial Pressure'}, {'measure': 'Block performance time in minutes', 'timeFrame': 'preoperative', 'description': 'Block performance time in minutes'}, {'measure': 'Incidence of adverse effects', 'timeFrame': '2 hours inPACU', 'description': 'Incidence of adverse effects'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Surgeries']}, 'descriptionModule': {'briefSummary': 'Dexmedetomidine used as an Additive for Ipack Block in Knee Surgery', 'detailedDescription': 'Many types of analgesia used but multimodal analgesia showed best results The interspace between the popliteal artery and capsule of the posterior knee (IPACK) block aims to blockade of sciatic nerve terminal branches for analgesia without motor affection\n\n. (IPACK) block is a motor power sparing procedure that involves injecting local anesthetic into the space between the popliteal artery and the posterior capsule of the knee in order to treat posterior knee pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 years\n* ASA I, II .patients undergoing knee surgeries.\n\nExclusion Criteria:\n\n* patient Refusal\n* bleeding disorders\n* skin lesion\n* infection\n* known allergy\n* contradictions of spinal anesthesia'}, 'identificationModule': {'nctId': 'NCT07058493', 'briefTitle': 'Dexmedetomidine as an Additive for (Ipack)Block in Knee Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Analgesic Effect of Using Dexmedetomidine as an Additive for (Ipack)Block in Knee Surgeries in Adult Patient; A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MS-491-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivacaine', 'description': 'IPACK block with 20ml bupivacaine 0.25% alone.\n\n.', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': 'IPACK block with 20 ml of bupivacaine 0.25% with dexmedetomidine 100 μg as adjuvant.', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'dexmedetomidine 100 μg as adjuvant to IPACK block with 20 ml of bupivacaine 0.25%.', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': '20 ml of bupivacaine 0.25%.', 'armGroupLabels': ['Bupivacaine']}]}, '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'}}}}