Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-02 @ 11:41 AM
Study NCT ID:
NCT02853669
Status:
UNKNOWN
Last Update Posted:
2016-08-03
First Post:
2016-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adductor Canal Block Versus Lumbar Plexus Block for Post Operative Pain Management After Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2016-07-24', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '2 hours', 'description': 'pain assessment using visual analogue scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain Management']}, 'descriptionModule': {'briefSummary': 'Adductor canal block (ACB), Saphenous nerve block, which is a block of a purely sensory nerve which shares in nerve supply of knee joint has a hypothetical advantage of better pain management with less motor affection. Also, it has a clear anatomical landmark that will increase the success rate (femoral artery) (\\*).On the other hand, being a branch of the femoral nerve and far distal from the plexus, this can decrease the blocking effectiveness. Likewise, the great variation of the knee nerve supply.\n\nThis prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy.\n\nThis study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.', 'detailedDescription': 'This prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy.\n\nThis study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* Age more than 25 and less than 80 were included\n\nExclusion Criteria:\n\n* Patients with known allergy to the medications to be given\n* ASA III, IV\n* Age less than 25 or more than 80\n* Dementia\n* Deafness\n* Psychological disease\n* Difficult to communicate\n* Cannot lay flat\n* INR more than 1.5\n* Low platelets (less than 100000/ml3) or with significant coagulopathy'}, 'identificationModule': {'nctId': 'NCT02853669', 'briefTitle': 'Adductor Canal Block Versus Lumbar Plexus Block for Post Operative Pain Management After Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Adductor Canal Block Versus Lumbar Plexus Block for Post Operative Pain Management After Total Knee Replacement', 'orgStudyIdInfo': {'id': 'adductor canal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group (A) lumber plexus block', 'description': 'Ultrasound-guided Lumber plexus Block (30 cc of 0.25% of bupivacaine, via a 22-gauge 2-inch Stimuplex A needle) with nerve stimulator confirmation.', 'interventionNames': ['Procedure: Ultrasound-guided Lumber Plexus Block']}, {'type': 'EXPERIMENTAL', 'label': 'Group (B) adductor canal block', 'description': 'ultrasound-guided Adductor Canal Block (15 cc of 0.5% of bupivacaine)', 'interventionNames': ['Procedure: adductor canal block']}], 'interventions': [{'name': 'Ultrasound-guided Lumber Plexus Block', 'type': 'PROCEDURE', 'description': '(30 cc of 0.25% of bupivacaine, via a 22-gauge 2-inch Stimuplex A needle) with nerve stimulator confirmation. The type of motor response (e.g., quadriceps, patellar) and the minimum current needed were recorded. Ultrasound pictures (preinjection and postinjection) were obtained to verify proper local anesthetic placement.', 'armGroupLabels': ['group (A) lumber plexus block']}, {'name': 'adductor canal block', 'type': 'PROCEDURE', 'otherNames': ['saphenous nerve block'], 'description': 'ultrasound-guided Adductor Canal Block (15 cc of 0.5% of bupivacaine)', 'armGroupLabels': ['Group (B) adductor canal block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1234', 'city': 'Cairo', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'HASSAN M ALI, LECTURER', 'role': 'CONTACT', 'email': 'hassan364@hotmail.com', 'phone': '+201001733687'}], 'facility': 'Cairo University'}], 'centralContacts': [{'name': 'Hassan Ali, lecturer', 'role': 'CONTACT', 'email': 'hassan364@hotmail.com', 'phone': '1001733687'}], 'overallOfficials': [{'name': 'Hassan Ali, LECTURER', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Anesthesia department, faculty of medicine ,Cairo university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer in anesthesia department Cairo university', 'investigatorFullName': 'Hassan Mohamed Ali', 'investigatorAffiliation': 'Cairo University'}}}}