Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-25 @ 2:38 PM
Study NCT ID:
NCT03401450
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'prianka.desai@nyulangone.org', 'phone': '212-263-5072', 'title': 'Dr. Prianka Desai', 'organization': 'NYU Langone'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'ACB Within True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine\n\nACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ACB Proximal to True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine\n\nACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACB Within True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine\n\nACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.'}, {'id': 'OG001', 'title': 'ACB Proximal to True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine\n\nACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine'}], 'classes': [{'categories': [{'measurements': [{'value': '23.21', 'spread': '12.23', 'groupId': 'OG000'}, {'value': '18.93', 'spread': '9.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Hours', 'description': 'Amount of morphine equivalents administered intraoperatively in 24 hours', 'unitOfMeasure': 'milligrams of morphine equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACB Within True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine\n\nACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.'}, {'id': 'OG001', 'title': 'ACB Proximal to True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine\n\nACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '6.79', 'groupId': 'OG000'}, {'value': '13.18', 'spread': '7.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Hours', 'description': 'Amount of morphine equivalents administered postoperatively in 24 hours', 'unitOfMeasure': 'mg of morphine equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Side Effects Such as Nausea, Itching, Constipation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACB Within True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine\n\nACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.'}, {'id': 'OG001', 'title': 'ACB Proximal to True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine\n\nACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Motor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACB Within True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine\n\nACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.'}, {'id': 'OG001', 'title': 'ACB Proximal to True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine\n\nACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine'}], 'timeFrame': '12 months', 'reportingStatus': 'POSTED', 'populationDescription': "This measure was not measured/assessed in study participants; the orthopedic surgeon's office did not perform this test in the clinic at any point of the study."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACB Within True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine\n\nACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.'}, {'id': 'FG001', 'title': 'ACB Proximal to True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine\n\nACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Anesthesia plan changed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Did not complete medication diary', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'post surgery medication change', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Cancelled surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ACB Within True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine\n\nACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.'}, {'id': 'BG001', 'title': 'ACB Proximal to True AC With Bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine\n\nACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-25 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': '26-35 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': '36-45 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': '46-55 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': '56-65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-01', 'size': 527620, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-01T12:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2018-01-10', 'resultsFirstSubmitDate': '2020-12-01', 'studyFirstSubmitQcDate': '2018-01-10', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-22', 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents', 'timeFrame': '24 Hours', 'description': 'Amount of morphine equivalents administered intraoperatively in 24 hours'}, {'measure': 'Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents', 'timeFrame': '24 Hours', 'description': 'Amount of morphine equivalents administered postoperatively in 24 hours'}, {'measure': 'Side Effects Such as Nausea, Itching, Constipation.', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': "Motor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months.", 'timeFrame': '12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACL Surgery']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, single blinded trial involving human subjects. The goal of this study is to determine an optimal location (proximal or distal) for the nerve block and whether it will make a difference in how much opioid the patient will receive during and after surgery. Ultrasound will identify the adductor canal and the proximal end of the adductor canal/apex of the femoral triangle to determine the location of the blocks.\n\nTheir will be two randomized groups: 1. ACB within true AC with bupivacaine 0.5% 20cc2. ACB proximal to true AC with bupivacaine 0.5% 20cc'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing unilateral, ACL surgery with allograft.\n* Patients who consent to be randomized.\n* Patients must be English proficient.\n\nExclusion Criteria:\n\n* Patients younger than 18 or older than 75 years of age;\n* Patients with a history of chronic pain or who are taking medications intended to treat chronic pain such as strong opioids;\n* Patients with history of neurologic disorder that can interfere with pain sensation;\n* Patients with a history of drug or alcohol abuse;\n* Patients who are unable to understand or follow instructions;\n* Patients with an allergy or a contraindication to any of the medications used in the study, or patients with a contraindication to any of the study procedures;\n* Patients with severe liver disease, renal insufficiency, congestive heart failure, and/ or significant heart disease;\n* Patients with a BMI over 42;\n* Any patient that the investigators feel cannot comply with all study related procedures.\n* Patients who do not tolerate Percocet.'}, 'identificationModule': {'nctId': 'NCT03401450', 'briefTitle': 'Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block', 'orgStudyIdInfo': {'id': '17-01602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACB within true AC with bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine', 'interventionNames': ['Drug: ACB within true AC with bupivacaine 0.5% 20cc']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ACB proximal to true AC with bupivacaine', 'description': 'The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine', 'interventionNames': ['Drug: ACB proximal to true AC with bupivacaine 0.5% 20cc']}], 'interventions': [{'name': 'ACB within true AC with bupivacaine 0.5% 20cc', 'type': 'DRUG', 'otherNames': ['bupivacaine'], 'description': 'The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.', 'armGroupLabels': ['ACB within true AC with bupivacaine']}, {'name': 'ACB proximal to true AC with bupivacaine 0.5% 20cc', 'type': 'DRUG', 'otherNames': ['bupivacaine'], 'description': 'Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine', 'armGroupLabels': ['ACB proximal to true AC with bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Prianka Desai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}