Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-07 @ 9:06 AM
Study NCT ID:
NCT02570503
Status:
TERMINATED
Last Update Posted:
2022-03-04
First Post:
2015-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'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': '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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'teresa.potter@vcuhealth.org', 'phone': '804-828-6749', 'title': 'Teresa Potter', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '48 hours post surgery', 'eventGroups': [{'id': 'EG000', 'title': 'ROP/KET/CLON/EPI/SAL', 'description': 'Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml\n\nRopivacaine: Ropivacaine (5mg/ml)-50ml\n\nKetorolac: ketorolac (30mg/ml)- 1 ml\n\nClonidine: clonidine (0.1mg/ml)- 0.8ml\n\nEpinephrine: epinephrine (1mg/ml)-1ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '0.9% Sodium Chloride- 100ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Universal Pain Assessment Tool (UPAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROP/KET/CLON/EPI/SAL', 'description': 'Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml\n\nRopivacaine: Ropivacaine (5mg/ml)-50ml\n\nKetorolac: ketorolac (30mg/ml)- 1 ml\n\nClonidine: clonidine (0.1mg/ml)- 0.8ml\n\nEpinephrine: epinephrine (1mg/ml)-1ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Sodium Chloride- 100ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}], 'timeFrame': '3 days after surgery', 'description': "Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.", 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported'}, {'type': 'PRIMARY', 'title': 'Narcotic Use During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROP/KET/CLON/EPI/SAL', 'description': 'Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml\n\nRopivacaine: Ropivacaine (5mg/ml)-50ml\n\nKetorolac: ketorolac (30mg/ml)- 1 ml\n\nClonidine: clonidine (0.1mg/ml)- 0.8ml\n\nEpinephrine: epinephrine (1mg/ml)-1ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Sodium Chloride- 100ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}], 'classes': [{'title': '0 to 24 hour post surgery period', 'categories': [{'measurements': [{'value': '58.9', 'spread': '41.2', 'groupId': 'OG000'}, {'value': '72.3', 'spread': '49.4', 'groupId': 'OG001'}]}]}, {'title': '24 to 48 hour post surgery period', 'categories': [{'measurements': [{'value': '66.5', 'spread': '51.3', 'groupId': 'OG000'}, {'value': '72.8', 'spread': '61.7', 'groupId': 'OG001'}]}]}, {'title': 'Full 48 hour post surgery period', 'categories': [{'measurements': [{'value': '125.6', 'spread': '80.7', 'groupId': 'OG000'}, {'value': '145.7', 'spread': '99.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period', 'description': 'The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.', 'unitOfMeasure': 'mg morphine equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Patient's Subjective Rating of Pain", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROP/KET/CLON/EPI/SAL', 'description': 'Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml\n\nRopivacaine: Ropivacaine (5mg/ml)-50ml\n\nKetorolac: ketorolac (30mg/ml)- 1 ml\n\nClonidine: clonidine (0.1mg/ml)- 0.8ml\n\nEpinephrine: epinephrine (1mg/ml)-1ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Sodium Chloride- 100ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}], 'timeFrame': '3 days after surgery', 'description': 'Patients are asked if their pain is acceptable (yes/no)', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported'}, {'type': 'SECONDARY', 'title': 'UPAT Score Before and After Physical Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROP/KET/CLON/EPI/SAL', 'description': 'Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml\n\nRopivacaine: Ropivacaine (5mg/ml)-50ml\n\nKetorolac: ketorolac (30mg/ml)- 1 ml\n\nClonidine: clonidine (0.1mg/ml)- 0.8ml\n\nEpinephrine: epinephrine (1mg/ml)-1ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Sodium Chloride- 100ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}], 'timeFrame': '3 days after surgery', 'description': 'Pain in score change after physical therapy', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported'}, {'type': 'SECONDARY', 'title': 'Ambulation During Physical Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROP/KET/CLON/EPI/SAL', 'description': 'Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml\n\nRopivacaine: Ropivacaine (5mg/ml)-50ml\n\nKetorolac: ketorolac (30mg/ml)- 1 ml\n\nClonidine: clonidine (0.1mg/ml)- 0.8ml\n\nEpinephrine: epinephrine (1mg/ml)-1ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Sodium Chloride- 100ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}], 'timeFrame': '48 hours after surgery', 'description': 'The length (in feet) patient is able to ambulate during physical therapy', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ROP/KET/CLON/EPI/SAL', 'description': 'Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml\n\nRopivacaine: Ropivacaine (5mg/ml)-50ml\n\nKetorolac: ketorolac (30mg/ml)- 1 ml\n\nClonidine: clonidine (0.1mg/ml)- 0.8ml\n\nEpinephrine: epinephrine (1mg/ml)-1ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}, {'id': 'FG001', 'title': 'Placebo', 'description': '0.9% Sodium Chloride- 100ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ROP/KET/CLON/EPI/SAL', 'description': 'Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml\n\nRopivacaine: Ropivacaine (5mg/ml)-50ml\n\nKetorolac: ketorolac (30mg/ml)- 1 ml\n\nClonidine: clonidine (0.1mg/ml)- 0.8ml\n\nEpinephrine: epinephrine (1mg/ml)-1ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}, {'id': 'BG001', 'title': 'Placebo', 'description': '0.9% Sodium Chloride- 100ml\n\n0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.0', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '64.6', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], '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'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], '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': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-08', 'size': 3560336, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-02T17:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': "Study's primary aims are no longer clinically impactful, as intrathecal morphine has fallen out of favor and replaced with different agents so that outpatient/23 hr surgery is more predictably achievable.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2015-10-05', 'resultsFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-02', 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Universal Pain Assessment Tool (UPAT)', 'timeFrame': '3 days after surgery', 'description': "Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery."}, {'measure': 'Narcotic Use During Hospitalization', 'timeFrame': '0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period', 'description': 'The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.'}], 'secondaryOutcomes': [{'measure': "Patient's Subjective Rating of Pain", 'timeFrame': '3 days after surgery', 'description': 'Patients are asked if their pain is acceptable (yes/no)'}, {'measure': 'UPAT Score Before and After Physical Therapy', 'timeFrame': '3 days after surgery', 'description': 'Pain in score change after physical therapy'}, {'measure': 'Ambulation During Physical Therapy', 'timeFrame': '48 hours after surgery', 'description': 'The length (in feet) patient is able to ambulate during physical therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels.\n\nApproximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups.\n\nAll patients will also receive a long-acting (24 hours) morphine injection during surgery.\n\nThe hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.', 'detailedDescription': "Data Collection:\n\nData will be collected from the patient's medical record after discharge\n\nVariables include:\n\n* Age\n* Sex\n* BMI\n* UPAT score (Universal Pain Assessment Tool)- this is assessed hourly postoperatively by nursing staff on Orthopedics Unit\n* Patient's assessment of acceptability of pain\n* UPAT score as assessed by physical therapy pre and post therapy sessions\n* Duramorph dose\n* Time patient arrived on the Orthopedic Unit\n* Length of ambulation during physical therapy sessions\n* Amount of supplementary opioids (measured in morphine equivalents)\n* Use of anti-emetics\n* Any complications of surgery including venous thromboembolic event, cardiac event, bleeding event\n* Length of hospital stay\n\nThe pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnant women\n* Creatinine clearance less than 60 ml/min\n* BMI greater than 40\n* Currently use greater than 80mg morphine-equivalents daily (pre-operatively)\n* Receive a unicondylar knee replacement'}, 'identificationModule': {'nctId': 'NCT02570503', 'briefTitle': 'Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Do Intraoperative Periarticular Injections Improve Postoperative Pain Control in Patients Receiving Duramorph (Preservative Free) During Total Knee Arthroplasty? A Prospective, Double-Blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HM20004125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ROP/KET/CLON/EPI/SAL', 'description': 'Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml', 'interventionNames': ['Drug: Ropivacaine', 'Drug: Ketorolac', 'Drug: Clonidine', 'Drug: Epinephrine', 'Drug: 0.9% sodium chloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% Sodium Chloride- 100ml', 'interventionNames': ['Drug: 0.9% sodium chloride']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['periarticular injection'], 'description': 'Ropivacaine (5mg/ml)-50ml', 'armGroupLabels': ['ROP/KET/CLON/EPI/SAL']}, {'name': 'Ketorolac', 'type': 'DRUG', 'otherNames': ['periarticular injection'], 'description': 'ketorolac (30mg/ml)- 1 ml', 'armGroupLabels': ['ROP/KET/CLON/EPI/SAL']}, {'name': 'Clonidine', 'type': 'DRUG', 'otherNames': ['periarticular injection'], 'description': 'clonidine (0.1mg/ml)- 0.8ml', 'armGroupLabels': ['ROP/KET/CLON/EPI/SAL']}, {'name': 'Epinephrine', 'type': 'DRUG', 'otherNames': ['periarticular injection'], 'description': 'epinephrine (1mg/ml)-1ml', 'armGroupLabels': ['ROP/KET/CLON/EPI/SAL']}, {'name': '0.9% sodium chloride', 'type': 'DRUG', 'otherNames': ['periarticular injection'], 'description': 'Sodium chloride 0.9%- 47.7 ml', 'armGroupLabels': ['Placebo', 'ROP/KET/CLON/EPI/SAL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Gregory Golladay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}