Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-02-02 @ 4:02 PM
Study NCT ID:
NCT04995861
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2021-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Between The Analgesic Efficacy of Adductor Canal Block Alone and Adductor Canal With IPACK (Interspace Between Popliteal Artery and Capsule of the Knee) Block for Knee Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2021-07-24', 'studyFirstSubmitQcDate': '2021-07-30', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of post operative pain', 'timeFrame': 'One year', 'description': 'Using visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain)'}], 'secondaryOutcomes': [{'measure': 'Range of movement and ambulation', 'timeFrame': 'One year', 'description': 'the range of movement (ROM) by assessing the degree of knee extension one day after the surgery, and ambulation distance assessed by the number of steps walked by the patient three days after the surgery.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nerve Blocks']}, 'descriptionModule': {'briefSummary': 'A comparison between The analgesic efficacy of adductor canal block alone and adductor canal with IPACK (interspace between popliteal artery and capsule of the knee) block for knee surgeries'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing knee surgery i.e. arthroscopy, total knee replacement, ACL repair.\n* ASA physical status I to III\n* Sex (males and females)\n* Age 21-70 years.\n\nExclusion Criteria:\n\n* Hypersensitivity to local anesthetics. Preexisting peripheral neuropathy. Infection near site of infections e.g. osteomyelitis, septic knee joint. Etc. Patient refusal. PAny contraindications for spinal anesthesia. ( eg: coagulopathy, use of anticoagulants'}, 'identificationModule': {'nctId': 'NCT04995861', 'briefTitle': 'A Comparison Between The Analgesic Efficacy of Adductor Canal Block Alone and Adductor Canal With IPACK (Interspace Between Popliteal Artery and Capsule of the Knee) Block for Knee Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'A Comparison Between The Analgesic Efficacy of Adductor Canal Block Alone and Adductor Canal With IPACK (Interspace Between Popliteal Artery and Capsule of the Knee) Block for Knee Surgeries', 'orgStudyIdInfo': {'id': 'AinShamsU Shabayek MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (adductor canal only)', 'description': 'Will recieve adductor canal block only', 'interventionNames': ['Procedure: Adductor canal block and IPACK block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group AB (adductor canal + IPACK)', 'description': 'Will recieve both adductor canal block and IPACK', 'interventionNames': ['Procedure: Adductor canal block and IPACK block']}], 'interventions': [{'name': 'Adductor canal block and IPACK block', 'type': 'PROCEDURE', 'description': 'Peripheral nerve blocks', 'armGroupLabels': ['Group A (adductor canal only)', 'Group AB (adductor canal + IPACK)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of anesthesia , intensive care and pain management', 'investigatorFullName': 'Mohammed Shabayek', 'investigatorAffiliation': 'Ain Shams University'}}}}