Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 1:21 PM
Study NCT ID:
NCT05473559
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2022-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient Undergoing Total Knee Arthroplasty. A Prospective Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine consumption', 'timeFrame': '24 hours post operative', 'description': '24 hours'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Analgesia']}, 'descriptionModule': {'briefSummary': 'Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient Undergoing Total Knee Arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty • Patients aged 40-80 years with a body mass index of 18-36 kg/ m2 and an American Society of Anesthesiologists functional status of I-III Planned use of regional anesthesia\n\nExclusion Criteria:\n\n* • Patients younger than 40 years old and older than 80years.\n\n * Hepatic or renal insufficiency.\n * Patients undergoing general anesthesia.\n * Allergy or intolerance to one of the study medications.\n * BMI \\> 36\n * Diabetes\n * ASA of IV\n * Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \\>5mg/day for one month)'}, 'identificationModule': {'nctId': 'NCT05473559', 'briefTitle': 'Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient Undergoing Total Knee Arthroplasty. A Prospective Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparison Between i Pack Block and Post Tibial Nerve Block', 'orgStudyIdInfo': {'id': '35151/12/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adductor canal block with Ipack block', 'interventionNames': ['Procedure: Adductor canal block with Ipack block or selective tibial nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adductor canal block with selective tibial nerve block', 'interventionNames': ['Procedure: Adductor canal block with Ipack block or selective tibial nerve block']}], 'interventions': [{'name': 'Adductor canal block with Ipack block or selective tibial nerve block', 'type': 'PROCEDURE', 'description': 'Ultrasound guided', 'armGroupLabels': ['Adductor canal block with Ipack block', 'Adductor canal block with selective tibial nerve block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta university', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Marwa Abogabal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}, {'name': 'Wafaa Abdelwahed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}, {'name': 'Wafaa Abdelsalam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kafr Elsheikh university'}, {'name': 'Shaimaa Zahra', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Marwa Ahmed Abogabal', 'investigatorAffiliation': 'Tanta University'}}}}