Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 6:00 PM
Study NCT ID:
NCT04639128
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2020-11-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adductor Canal Catheter Effectiveness and Safety Study
Sponsor:
Organization:
Raw JSON
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'description': 'No placement of an adductor canal catheter', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Device', 'description': 'Placement of an adductor canal catheter\n\nAdductor Canal Catheter: The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small-bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Numerical Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No-Device', 'description': 'No placement of an adductor canal catheter'}, {'id': 'OG001', 'title': 'Device', 'description': 'Placement of an adductor canal catheter\n\nAdductor Canal Catheter: The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days'}], 'classes': [{'categories': [{'measurements': [{'value': '6.38', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '5.31', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Second postoperative day', 'description': 'Ordinal 0-to-10 point scale of pain severity Minimum value: 0 Maximum value: 10 Higher scores mean more pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Had surgery and able to provide postoperative day-2 pain score'}, {'type': 'SECONDARY', 'title': 'Opioid Consumption in the 15-day Postoperative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No-Device', 'description': 'No placement of an adductor canal catheter'}, {'id': 'OG001', 'title': 'Device', 'description': 'Placement of an adductor canal catheter\n\nAdductor Canal Catheter: The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days'}], 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'spread': '4.20', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '5.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 postoperative days', 'description': 'Total number of 5mg oxycodone tablets (provided to all patients on discharge) consumed over the 15-day postoperative period as recorded in the daily pain-and-medication postoperative diary', 'unitOfMeasure': '5mg oxycodone tablets', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers of participants do not equal those of the pain-score analyses due to missing data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No-Device', 'description': 'No placement of an adductor canal catheter'}, {'id': 'FG001', 'title': 'Device', 'description': 'Placement of an adductor canal catheter\n\nAdductor Canal Catheter: The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No-Device', 'description': 'No placement of an adductor canal catheter'}, {'id': 'BG001', 'title': 'Device', 'description': 'Placement of an adductor canal catheter\n\nAdductor Canal Catheter: The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '66.5', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '66.5', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', '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': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', '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': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '81', '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': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-26', 'size': 449544, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-26T20:03', 'hasProtocol': True}, {'date': '2020-10-06', 'size': 249208, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-11-16T11:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2020-11-05', 'resultsFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-23', 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Numerical Rating Scale', 'timeFrame': 'Second postoperative day', 'description': 'Ordinal 0-to-10 point scale of pain severity Minimum value: 0 Maximum value: 10 Higher scores mean more pain'}], 'secondaryOutcomes': [{'measure': 'Opioid Consumption in the 15-day Postoperative Period', 'timeFrame': '15 postoperative days', 'description': 'Total number of 5mg oxycodone tablets (provided to all patients on discharge) consumed over the 15-day postoperative period as recorded in the daily pain-and-medication postoperative diary'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['analgesia', 'surgery', 'device'], 'conditions': ['Total Knee Replacement Surgery']}, 'referencesModule': {'references': [{'pmid': '26227922', 'type': 'BACKGROUND', 'citation': 'Song MH, Kim BH, Ahn SJ, Yoo SH, Kang SW, Kim YJ, Kim DH. Peri-articular injections of local anaesthesia can replace patient-controlled analgesia after total knee arthroplasty: a randomised controlled study. Int Orthop. 2016 Feb;40(2):295-9. doi: 10.1007/s00264-015-2940-2. Epub 2015 Jul 31.'}, {'pmid': '19916251', 'type': 'BACKGROUND', 'citation': 'Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.'}, {'pmid': '24401769', 'type': 'BACKGROUND', 'citation': 'Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.'}]}, 'descriptionModule': {'briefSummary': 'PRIMARY OBJECTIVE: Compare the effect of usual care with an adductor canal catheter (ACC) containing ropivacaine to the effect of usual care without an ACC on the second-postoperative-day pain levels among patients undergoing elective primary unilateral total knee arthroplasty (TKA)\n\nSECONDARY OBJECTIVES: Among a sample of patients undergoing elective primary unilateral TKA who receive peri-articular anesthetic injections:\n\n1. To compare the overall two-week levels of postoperative pain between those participants randomized to ACCs containing ropivacaine and those participants randomized to usual care without an ACC\n2. To compare the use of opioid medications (in mean total morphine milligram equivalents) between those participants randomized to ACCs containing ropivacaine and those participants randomized to usual care without an ACC over the two-week postoperative period\n3. To describe the incidence of complications related to ACC placement including infection, displacement, ACC-related clinic or emergency department (ED) visits\n4. To conduct exploratory analyses to identify candidate predictors of differential response to the ACC', 'detailedDescription': 'DESIGN: Randomized, open-label, two-arm, parallel-comparison noninferiority trial\n\nPOPULATION: Adults aged \\>18 years intending to undergo elective primary unilateral TKA at the Kaiser Permanente Northern California (KPNC), San Leandro Medical Center\n\nINTERVENTION: Participants will be randomized to one of two treatment arms:\n\n1. Adductor canal catheter placement in the pre-operative area immediately prior to TKA surgery OR\n2. No adductor canal catheter placement\n\nDURATION: The intervention phase will occur between randomization and three days postoperatively (or until the ACC is removed by the participant or the ACC falls out spontaneously among ACC-randomized participants); the primary outcome will be measured on postoperative day 2, secondary pain and medication outcomes will be collected for two weeks postoperatively and the electronic medical record (EMR) will be examined for evidence of adverse events at 30 days postoperatively\n\nSAMPLE SIZE: 118 participants randomized using balanced allocation to the two study arms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intending to undergo elective primary unilateral TKA at the Kaiser Permanente Northern California, San Leandro Medical Center\n* Patient ambulates independently\n\nExclusion Criteria:\n\n* Patient declines use of ACC\n* Surgeon decides that an ACC will not be placed for any reason\n* Known hypersensitivity to ropivacaine or any alternative anesthetic for ACC use\n* Hypersensitivity or inability to tolerate peri-articular injections of clonidine, epinephrine, bupivacaine and ketorolac\n* Any evidence of substance-use disorder in past year\n* Non-English speaking\n* Failure to complete all baseline study instruments prior to surgery\n* Requires secondary procedure at time of TKA (e.g., removal of hardware)\n* Not intending to use spinal anesthesia for TKA procedure\n* Actively enrolled in KPNC chronic-pain program\n* Having been prescribed long-acting opioid (e.g., Oxycontin, MS Contin) within 90 days prior to enrollment\n* Inability to tolerate any oral NSAID or acetaminophen or any short-acting opioid'}, 'identificationModule': {'nctId': 'NCT04639128', 'acronym': 'ACCESS', 'briefTitle': 'Adductor Canal Catheter Effectiveness and Safety Study', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'An Open-Label Randomized Noninferiority Clinical Trial of the Adductor Canal Catheter for Pain Control Post-Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '1488728'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No-Device', 'description': 'No placement of an adductor canal catheter'}, {'type': 'EXPERIMENTAL', 'label': 'Device', 'description': 'Placement of an adductor canal catheter', 'interventionNames': ['Device: Adductor Canal Catheter']}], 'interventions': [{'name': 'Adductor Canal Catheter', 'type': 'DEVICE', 'description': 'The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days', 'armGroupLabels': ['Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94577', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Leandro', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}], 'overallOfficials': [{'name': 'Adrian Hinman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Consideration for sharing patient-level data will be made on case-by-case basis via contact with the study PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}