Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-01 @ 10:42 PM
Study NCT ID:
NCT06404658
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of Genicular Nerve Block Versus (IPack Block ) in Patients Undergoing (ACL) Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-12', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-05-04', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS score', 'timeFrame': '48 hour', 'description': 'Measuring pain intensity regarding mean visual analogue score (VAS score ) ranging from 0 (no pain) to 10 (the worst imaginable pain.'}], 'secondaryOutcomes': [{'measure': 'Ambulatory score', 'timeFrame': 'Within 48 hour', 'description': 'Ambulatory score from ( 0 to 2) (score of 0) is assigned if the activity cannot be performed despite substantial help\n\n(score of 1 )is assigned if the activity is performed using personal physical support.\n\n(score of 2) is assigned if the activity is performed independently.'}, {'measure': 'Time of first rescue analgesia', 'timeFrame': 'within 24 hour', 'description': 'the time to ask for the first post operative analgesia'}, {'measure': 'Total opioid consumption post operative', 'timeFrame': 'Within 24 hour', 'description': 'Total opioid consumption post operative'}, {'measure': 'Incidence of occurrence of systemic toxicity', 'timeFrame': 'Within 24 hour', 'description': '( hypotension ,arrthymias, bradycardia, cardiac arrest, oral numbness and convulsions'}, {'measure': 'The length of hospital stay .', 'timeFrame': 'within one week', 'description': 'The length of hospital stay .'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'One of the most common injuries to the knee is an anterior cruciate ligament (ACL) sprain or tear due to trauma ACL damage is crippling and often requires repair with an arthroscopic method, which is an outpatient surgery. Nevertheless, patients experience severe postoperative pain on the first day after the ACL reconstruction.Efficient postsurgery pain management is an important part of patient recovery that is also crucial for their satisfaction.', 'detailedDescription': 'The optimum role of peripheral nerve blocks in ACL reconstruction continue to be debated as a component of multi-modal analgesia . As such ,an ideal block for ACLR would target sensation but not motor function,have minimal complication risk,and be easily reproducible The genicular nerves include branches from the femoral, common peroneal, saphenous, tibial, and obturator nerves which innervate the knee capsule . The superolateral, superomedial, and inferomedial On the other hand, the interspace between the Popliteal Artery and Capsule of the Knee (IPACK) block provides analgesia on the posterior knee joint, and the application of a genicular or IPACK block has been be associated with promising outcomes following the ACLR surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patient age from 18 to 45 years old Patient status ASA I - II Patient body mass index (BMI) \\<40 kg/m2\n\nExclusion Criteria:\n\n* -Patients were excluded if they refused consent.\n* Patients who are Not cooperative.\n* BMI \\>40 kg/m2.\n* Allergy to local anesthetics.\n* Patients with anticoagulation or bleeding problems.\n* Previous nerve dysfunction.\n* Physical status ASA class IV.'}, 'identificationModule': {'nctId': 'NCT06404658', 'briefTitle': 'Analgesic Efficacy of Genicular Nerve Block Versus (IPack Block ) in Patients Undergoing (ACL) Repair', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Analgesic Efficacy of Genicular Nerve Block Versus Local Anaesthetic Infiltration Between Popliteal Artery and Capsule of the Knee (IPACK Block ) in Patients Undergoing Anterior Cruciate Ligament (ACL) Repair by Knee Arthroscopy . A Randomized Controlled Prospective Study .', 'orgStudyIdInfo': {'id': 'FMBSUREC/02012024/Kamal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'did not receive any block just spinal anathesia.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Genicular nerve block', 'description': 'patients who receive Genicular nerve block with spinal anathesia .', 'interventionNames': ['Procedure: Genicular nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IPACK block', 'description': 'patients who receive IPACK block with spinal anathesia.', 'interventionNames': ['Procedure: Genicular nerve block']}], 'interventions': [{'name': 'Genicular nerve block', 'type': 'PROCEDURE', 'description': 'patients who receive Genicular nerve block with spinal anathesia .', 'armGroupLabels': ['Genicular nerve block', 'IPACK block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Benisuef', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mariana AbdElsayed Mansour, MD', 'role': 'CONTACT', 'email': 'mrmrsyk4@gmail.com', 'phone': '01222960009'}], 'facility': 'Benisuef University Hospital'}], 'centralContacts': [{'name': 'Mariana AbdElsayed Mansour', 'role': 'CONTACT', 'email': 'mrmrsyk4@gmail.com', 'phone': '01222960009', 'phoneExt': 'MD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anaesthesia, surgical intensive care and pain managment', 'investigatorFullName': 'Mariana Soliman', 'investigatorAffiliation': 'Beni-Suef University'}}}}