Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-02 @ 4:56 PM
Study NCT ID:
NCT03353233
Status:
COMPLETED
Last Update Posted:
2021-12-21
First Post:
2017-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D003766', 'term': 'Dental Occlusion'}, {'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': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'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': 'william.bullock@duke.edu', 'phone': '919-681-6437', 'title': 'W. Michael Bullock, MD, PhD', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Technical problems with allocations leading to unrelabile and uninterpretable data.'}}, 'adverseEventsModule': {'timeFrame': 'From enrollment in study until 24 hours post-op.', 'eventGroups': [{'id': 'EG000', 'title': 'iPACK Block Group', 'description': 'A nerve block technique using a numbing medication called ropivacaine.\n\nRopivacaine: Local anesthetic (numbing drug)\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Group', 'description': 'The same nerve block technique as above, however using an inactive solution of salt water.\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.\n\nSaline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Able to Hyperextend the Knee After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iPACK Block Group', 'description': 'A nerve block technique using a numbing medication called ropivacaine.\n\nRopivacaine: Local anesthetic (numbing drug)\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'The same nerve block technique as above, however using an inactive solution of salt water.\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.\n\nSaline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 8 hours', 'description': 'Ability to hyperextend the knee after surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ambulation as Measured by Distance Walked After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iPACK Block Group', 'description': 'A nerve block technique using a numbing medication called ropivacaine.\n\nRopivacaine: Local anesthetic (numbing drug)\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'The same nerve block technique as above, however using an inactive solution of salt water.\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.\n\nSaline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.'}], 'classes': [{'categories': [{'measurements': [{'value': '120.36', 'spread': '123.1', 'groupId': 'OG000'}, {'value': '148.8', 'spread': '108.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-operative Day 0', 'unitOfMeasure': 'feet', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain as Measure by Numerical Rating Scale (NRS) 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iPACK Block Group', 'description': 'A nerve block technique using a numbing medication called ropivacaine.\n\nRopivacaine: Local anesthetic (numbing drug)\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'The same nerve block technique as above, however using an inactive solution of salt water.\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.\n\nSaline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.64', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '5', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'The 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable").', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iPACK Block Group', 'description': 'A nerve block technique using a numbing medication called ropivacaine.\n\nRopivacaine: Local anesthetic (numbing drug)\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'The same nerve block technique as above, however using an inactive solution of salt water.\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.\n\nSaline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.52', 'spread': '39.54', 'groupId': 'OG000'}, {'value': '48.98', 'spread': '36.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Total amount of opioids used', 'unitOfMeasure': 'IV morphine equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'iPACK Block Group', 'description': 'A nerve block technique using a numbing medication called ropivacaine.\n\nRopivacaine: Local anesthetic (numbing drug)\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.'}, {'id': 'FG001', 'title': 'Sham Group', 'description': 'The same nerve block technique as above, however using an inactive solution of salt water.\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.\n\nSaline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'iPACK Block Group', 'description': 'A nerve block technique using a numbing medication called ropivacaine.\n\nRopivacaine: Local anesthetic (numbing drug)\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.'}, {'id': 'BG001', 'title': 'Sham Group', 'description': 'The same nerve block technique as above, however using an inactive solution of salt water.\n\nInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.\n\nSaline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.84', 'spread': '6.39', 'groupId': 'BG000'}, {'value': '64.59', 'spread': '7.01', 'groupId': 'BG001'}, {'value': '65.71', 'spread': '6.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-06', 'size': 125794, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-22T16:14', 'hasProtocol': True}, {'date': '2021-01-06', 'size': 147787, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-11-19T14:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-22', 'studyFirstSubmitDate': '2017-11-21', 'resultsFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-22', 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Able to Hyperextend the Knee After Surgery', 'timeFrame': 'Within 8 hours', 'description': 'Ability to hyperextend the knee after surgery'}], 'secondaryOutcomes': [{'measure': 'Ambulation as Measured by Distance Walked After Surgery', 'timeFrame': 'Post-operative Day 0'}, {'measure': 'Pain as Measure by Numerical Rating Scale (NRS) 11', 'timeFrame': '24 hours', 'description': 'The 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable").'}, {'measure': 'Cumulative Opioid Consumption', 'timeFrame': '24 hours', 'description': 'Total amount of opioids used'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iPACK', 'Interspace between the Popliteal Artery and Capsule of the Knee', 'Posterior Capsule block', 'Nerve Block'], 'conditions': ['Knee Osteoarthritis', 'Primary Total Knee Arthroplasty', 'Physical Therapy', 'Pain', 'Knee Extension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn if using an Interspace between the Popliteal Artery and Capsule of the Knee (iPACK) injection technique (also called a "nerve block") that numbs the nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK technique uses a numbing solution (local anesthetics) that is injected behind the knee to reduce pain and to help straighten the knee. This block may affect movement in the leg and make the legs weak, but thing is rare. A few institutions use the iPACK block for patients having total knee replacements, with the hope of providing good pain relief combined with improved mobility after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* English speaking\n* Between 18 and 75 years old\n* American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty\n\nExclusion Criteria:\n\n* ASA 4 or 5\n* Revision knee arthroplasty\n* Diagnosis of chronic pain\n* Daily chronic opioid use (over 3 months of continuous opioid use)\n* Inability to communicate pain scores or need for analgesia\n* Acute knee dislocation/fracture\n* Infection at the site of block placement\n* Age under 18 years old or greater than 75 years old\n* Pregnant women\n* Intolerance/allergy to local anesthetics\n* Weight \\<50 kg\n* Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.\n* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance\n* Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course."}, 'identificationModule': {'nctId': 'NCT03353233', 'briefTitle': 'Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.', 'orgStudyIdInfo': {'id': 'Pro00070573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iPACK Block Group', 'description': 'A nerve block technique using a numbing medication called ropivacaine.', 'interventionNames': ['Drug: Ropivacaine', 'Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham Group', 'description': 'The same nerve block technique as above, however using an inactive solution of salt water.', 'interventionNames': ['Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block', 'Drug: Saline']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Naropin'], 'description': 'Local anesthetic (numbing drug)', 'armGroupLabels': ['iPACK Block Group']}, {'name': 'Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block', 'type': 'PROCEDURE', 'otherNames': ['iPACK', 'Posterior Capsule'], 'description': 'An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.', 'armGroupLabels': ['Sham Group', 'iPACK Block Group']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Salt water placebo'], 'description': 'An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.', 'armGroupLabels': ['Sham Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}