Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-02-25 @ 4:15 AM
Study NCT ID:
NCT02276495
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2014-10-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Can Single-Injection Adductor Canal Blocks Improve PostOp Pain Relief in Patients Undergoing Total Knee Arthroplasty?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jrinehar@hs.uci.edu', 'phone': '714-456-7415', 'title': 'Dr. Joseph Rinehart', 'organization': 'UC Irvine Health Department of Anesthesiology & Perioperative Care'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The PI changed twice during the study period, and the final PI left after the beginning of the COVID-19 pandemic. We have endeavored to collect as much of the original study data as possible in order to close out this record, but many measures were not collected (baseline anxiety \\& pain, NRS scores, etc). We have reported as much as possible based on hospital records and existing data that was collected during the study period.'}}, 'adverseEventsModule': {'timeFrame': 'All subjects were followed to 30 days post-operatively', 'eventGroups': [{'id': 'EG000', 'title': 'Joint Infiltration Only', 'description': 'ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ACB + Joint Infiltration', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'ACB Only', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Joint Infiltration Only', 'description': 'ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG001', 'title': 'ACB + Joint Infiltration', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG002', 'title': 'ACB Only', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '6'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '0.668', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'within 24 hours postoperative', 'description': 'The primary outcome variable of interest is the median maximum pain score within 24 hours postoperative. Pain scores were rated on a scale from 0 - 10, with 0 being no discomfort/pain and 10 being worst imaginable pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Joint Infiltration Only', 'description': 'ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG001', 'title': 'ACB + Joint Infiltration', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG002', 'title': 'ACB Only', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '66'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '22'}, {'value': '26', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '45'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'within 24 hours postoperative', 'description': '24 Hour post-surgical opioid use', 'unitOfMeasure': 'Daily mg morphine equivalents', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ambulation Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Joint Infiltration Only', 'description': 'ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG001', 'title': 'ACB + Joint Infiltration', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG002', 'title': 'ACB Only', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)'}], 'classes': [{'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '360'}, {'value': '350', 'groupId': 'OG001', 'lowerLimit': '225', 'upperLimit': '370'}, {'value': '95', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '160'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'First 24 hours post-operative', 'description': 'Total distance ambulated during physical therapy during first 24 hours', 'unitOfMeasure': 'feet', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Joint Infiltration Only', 'description': 'ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG001', 'title': 'ACB + Joint Infiltration', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG002', 'title': 'ACB Only', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)'}], 'timeFrame': 'pre-operative day of surgery', 'description': 'Self-reported subject anxiety prior to surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was incompletely collected across the study so no analysis performed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Baseline Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Joint Infiltration Only', 'description': 'ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG001', 'title': 'ACB + Joint Infiltration', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG002', 'title': 'ACB Only', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)'}], 'timeFrame': 'Preoperatively day of surgery', 'description': 'Baseline pain preoperatively', 'reportingStatus': 'POSTED', 'populationDescription': 'Study data was incompletely collected across the study period so no analysis was performed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'NRS Pain Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Joint Infiltration Only', 'description': 'ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG001', 'title': 'ACB + Joint Infiltration', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'OG002', 'title': 'ACB Only', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)'}], 'timeFrame': 'Preop, PACU, and 4,8, 12, and 24 hours post-operatively.', 'description': 'A modified pain score similar to VAS but rated from 0-10', 'reportingStatus': 'POSTED', 'populationDescription': 'NRS scores were not collected during the study, so no analysis is performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Joint Infiltration Only', 'description': 'ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'FG001', 'title': 'ACB + Joint Infiltration', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'FG002', 'title': 'ACB Only', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from the main operating room from January 2015 through December of 2019. Recruitment was prolonged due to PI changes secondary to personnel leaving the university.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ACB Control + Local Infiltration', 'description': 'ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Control - 20 ml saline injection for ACB: Adductor Canal Block Control (20 ml saline injection)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'BG001', 'title': 'ACB Study + Local Infiltration', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)\n\nLocal infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline: 100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)'}, {'id': 'BG002', 'title': 'ACB Study Only', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block\n\nACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block: Adductor Canal Block Study (20 ml 0.5% Ropivacaine)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '74'}, {'value': '68', 'groupId': 'BG001', 'lowerLimit': '63', 'upperLimit': '71'}, {'value': '67', 'groupId': 'BG002', 'lowerLimit': '62', 'upperLimit': '76'}, {'value': '67', 'groupId': 'BG003', 'lowerLimit': '61', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (cm)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000', 'lowerLimit': '160', 'upperLimit': '179'}, {'value': '167', 'groupId': 'BG001', 'lowerLimit': '162', 'upperLimit': '175'}, {'value': '169', 'groupId': 'BG002', 'lowerLimit': '156', 'upperLimit': '175'}, {'value': '169', 'groupId': 'BG003', 'lowerLimit': '160', 'upperLimit': '175'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Weight (lbs)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '198', 'groupId': 'BG000', 'lowerLimit': '148', 'upperLimit': '214'}, {'value': '207', 'groupId': 'BG001', 'lowerLimit': '170', 'upperLimit': '219'}, {'value': '181', 'groupId': 'BG002', 'lowerLimit': '166', 'upperLimit': '194'}, {'value': '188', 'groupId': 'BG003', 'lowerLimit': '154', 'upperLimit': '214'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-19', 'size': 1141544, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-23T15:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2014-10-20', 'resultsFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2014-10-24', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-28', 'studyFirstPostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Baseline Anxiety', 'timeFrame': 'pre-operative day of surgery', 'description': 'Self-reported subject anxiety prior to surgery'}, {'measure': 'Baseline Pain Score', 'timeFrame': 'Preoperatively day of surgery', 'description': 'Baseline pain preoperatively'}, {'measure': 'NRS Pain Rating', 'timeFrame': 'Preop, PACU, and 4,8, 12, and 24 hours post-operatively.', 'description': 'A modified pain score similar to VAS but rated from 0-10'}], 'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'within 24 hours postoperative', 'description': 'The primary outcome variable of interest is the median maximum pain score within 24 hours postoperative. Pain scores were rated on a scale from 0 - 10, with 0 being no discomfort/pain and 10 being worst imaginable pain.'}], 'secondaryOutcomes': [{'measure': 'Opioid Use', 'timeFrame': 'within 24 hours postoperative', 'description': '24 Hour post-surgical opioid use'}, {'measure': 'Ambulation Distance', 'timeFrame': 'First 24 hours post-operative', 'description': 'Total distance ambulated during physical therapy during first 24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pain management for total knee arthroplasty'], 'conditions': ['Pain Management']}, 'referencesModule': {'references': [{'pmid': '21388906', 'type': 'BACKGROUND', 'citation': 'Wylde V, Rooker J, Halliday L, Blom A. Acute postoperative pain at rest after hip and knee arthroplasty: severity, sensory qualities and impact on sleep. Orthop Traumatol Surg Res. 2011 Apr;97(2):139-44. doi: 10.1016/j.otsr.2010.12.003. Epub 2011 Mar 8.'}, {'pmid': '23891055', 'type': 'BACKGROUND', 'citation': 'Robbins SM, Rastogi R, McLaughlin TL. Predicting acute recovery of physical function following total knee joint arthroplasty. J Arthroplasty. 2014 Feb;29(2):299-303. doi: 10.1016/j.arth.2013.06.033. Epub 2013 Jul 26.'}, {'pmid': '16698416', 'type': 'BACKGROUND', 'citation': 'Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.'}, {'pmid': '19606021', 'type': 'BACKGROUND', 'citation': 'Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a.'}, {'pmid': '20966667', 'type': 'BACKGROUND', 'citation': 'Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18.'}, {'pmid': '19553071', 'type': 'BACKGROUND', 'citation': 'Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24.'}, {'pmid': '24121608', 'type': 'BACKGROUND', 'citation': 'Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.'}, {'pmid': '23897505', 'type': 'BACKGROUND', 'citation': 'Mudumbai SC, Kim TE, Howard SK, Workman JJ, Giori N, Woolson S, Ganaway T, King R, Mariano ER. Continuous adductor canal blocks are superior to continuous femoral nerve blocks in promoting early ambulation after TKA. Clin Orthop Relat Res. 2014 May;472(5):1377-83. doi: 10.1007/s11999-013-3197-y.'}, {'pmid': '22325963', 'type': 'BACKGROUND', 'citation': 'Ng FY, Ng JK, Chiu KY, Yan CH, Chan CW. Multimodal periarticular injection vs continuous femoral nerve block after total knee arthroplasty: a prospective, crossover, randomized clinical trial. J Arthroplasty. 2012 Jun;27(6):1234-8. doi: 10.1016/j.arth.2011.12.021. Epub 2012 Feb 8.'}, {'pmid': '23783531', 'type': 'BACKGROUND', 'citation': 'Teng Y, Jiang J, Chen S, Zhao L, Cui Z, Khan MS, Du W, Gao X, Wang J, Xia Y. Periarticular multimodal drug injection in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1949-57. doi: 10.1007/s00167-013-2566-0. Epub 2013 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the effect of a single injection adductor canal block (ACB) on pain scores within 24 hours post total knee arthroplasty (TKA).', 'detailedDescription': 'Total knee arthroplasty (TKA), also known as total knee replacement, has been associated with a significant pain burden in the postoperative period. Methods to manage pain associated with this operation have in the past included injecting pain medication into the epidural space of the spinal cord, around a peripheral nerve, around the space surrounding the joint, or a combination of pain management techniques.\n\nIn recent years, the femoral nerve block (injection of pain medication around the peripheral nerve, specifically the femoral nerve) has been proposed as an effective way to manage pain while sparing many of the undesirable side effects of narcotic pain medications. Traditional techniques of the femoral nerve block involve the injection of pain medication around the peripheral nerve at the level of the groin area. A nerve block at this point in the path of the femoral nerve affects all of the musculature of the front part of the thigh as well as the nerves responsible for sensation to the majority of the knee joint. The femoral nerve block performed at the level of the groin provides an excellent level of pain relief at the knee joint, but is also associated with weakness of the quadriceps muscle. The resultant quadriceps weakness can both slow the physical therapy process and be a risk factor for post-operative falls. Participation in physical therapy is a critical component of the rehabilitation process and is started as soon as tolerated by the patient. The ideal pain management technique would provide the same degree of pain relief as the femoral nerve block while preserving the strength in the front part of the thigh muscles.\n\nOne suggested technique to achieve both of these goals is the injection of a large volume dilute local pain medication mixture around the joint during surgery. This has been used as a substitute to provide pain relief around the joint while maintaining strength in the quadriceps muscle and the ability to participate in physical therapy. This technique however, does not last long since the medication disperses away from the joint space.\n\nA variation of the femoral nerve block in the lower thigh, within a space called the adductor canal, has been demonstrated to provide equivalent amounts of pain relief as a proximal femoral nerve block along with preservation of motor function to the quadriceps muscle. What is not as well-established is whether the combination of injecting pain medication directly around the joint space in the knee along with a single injection of pain medication in the adductor canal in the lower thigh can improve pain scores and extend the duration of pain relief provided compared to only an injection around the joint space.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and Females age 18+ years old having total knee arthroplasty (TKA) at UCI Medical Center\n* American Society of Anesthesiologists physical status I to III\n\nExclusion Criteria:\n\n* Allergy to local anesthetics\n* Pregnancy\n* Nursing Mothers\n* Children \\<18 years of age\n* Renal impairment (GFR\\<60 mL/min/1.73m2)\n* Hepatic Impairment (active hepatitis, elevated AST or ALT, jaundice)\n* Opioid tolerant patients (defined as greater than 30 mg Morphine equivalent consumed daily)\n* Patients that are diabetic with peripheral neuropathy\n* BMI greater than 40'}, 'identificationModule': {'nctId': 'NCT02276495', 'briefTitle': 'Can Single-Injection Adductor Canal Blocks Improve PostOp Pain Relief in Patients Undergoing Total Knee Arthroplasty?', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Does Single Injection Adductor Canal Block Improve Postoperative Analgesia in Patients Receiving Periarticular Local Anesthesia Injections for Total Knee Arthroplasty?', 'orgStudyIdInfo': {'id': '20141217'}, 'secondaryIdInfos': [{'id': 'UCIANES06', 'type': 'OTHER', 'domain': 'UCIANE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACB Control + Local Infiltration', 'description': 'ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline', 'interventionNames': ['Other: ACB Control - 20 ml saline injection for ACB', 'Drug: Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'ACB Study + Local infiltration', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline', 'interventionNames': ['Drug: ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block', 'Drug: Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'ACB Study Only', 'description': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block', 'interventionNames': ['Drug: ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block']}], 'interventions': [{'name': 'ACB Control - 20 ml saline injection for ACB', 'type': 'OTHER', 'description': 'Adductor Canal Block Control (20 ml saline injection)', 'armGroupLabels': ['ACB Control + Local Infiltration']}, {'name': 'ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block', 'type': 'DRUG', 'description': 'Adductor Canal Block Study (20 ml 0.5% Ropivacaine)', 'armGroupLabels': ['ACB Study + Local infiltration', 'ACB Study Only']}, {'name': 'Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline', 'type': 'DRUG', 'description': '100 mLs of a solution containing:\n\nRopivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)', 'armGroupLabels': ['ACB Control + Local Infiltration', 'ACB Study + Local infiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Joseph Rinehart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor', 'investigatorFullName': 'Joseph Brian Rinehart', 'investigatorAffiliation': 'University of California, Irvine'}}}}