Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2026-04-02 @ 7:09 AM
Study NCT ID:
NCT02616367
Status:
WITHDRAWN
Last Update Posted:
2019-05-01
First Post:
2015-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Comparison of Ropivacaine and Liposomal Bupivacaine for Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study never initiated', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-29', 'studyFirstSubmitDate': '2015-11-24', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain control measure on pain scale of 1-10', 'timeFrame': '72 hours', 'description': 'to determine if liposomal bupivacaine provides superior pain control (decreased maximal pain control (decreased maximal pain scores) when compared to ropivacaine when injected in a periarticular injection.'}], 'secondaryOutcomes': [{'measure': 'decreased maximal pain on pain scale of 1-10', 'timeFrame': '72 hours', 'description': 'Liposomal bupivacaine via a periarticular injection will result in a decreased maximal pain and improved quality of recovery when compared to ropivacaine when injected in a periarticular injection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthroplasty', 'Replacement', 'Knee']}, 'descriptionModule': {'briefSummary': 'This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine for a periarticular injection. The other will receive ropivacaine for periarticular injection for pain relief after Total Knee Arthroplasty. the primary objective of this study is to determine if liposomal bupivacaine provides superior pain control (decreased maximal pain scores within the first 72 hours post surgery) when compared to ropivacaine when injected in a periarticular injection.', 'detailedDescription': 'The current standard of care at our institution for pain relief in Total Knee Arthroplasty is ropivacaine injectate into the knee for acute postoperative pain relief. This provides pain relief for a duration of 6-18 hours after surgery. All patients in this study will also receive multimodal analgesia following surgery in both arms of the study. This will be the first study to prospectively analyze these two regimens.\n\nStudy group 1 (ropivacaine arm) consist of 100 mL (1 mL ketorolac, 2.5 mL morphine, 28.95 mL normal saline, 300 mcg of epinephrine, and 200 mg ropivacaine) Study group 2 will consist of 100 mL (one syringe with 50 mL total: 40 mL 0.25% bupivacaine, 300 mcg epinephrine, 1 mL ketorolac, 2.5 mL morphine, 6.5 mL normal saline) (one syringe with 50 mL total: 20 mL liposomal bupivacaine 30 mL normal saline). The periarticular injection will occur at the end of the procedure. Adequate analgesia will be defined as \\< 3 VAS at rest and if VAS is greater that 3 adjustments in oral or intravenous pain medications. Postoperatively the study team will evaluate for any signs of complications. Pain scores and opioid usage will be recorded daily while the subject is in the hospital. A quality of recovery survey will be completed at 72 hours post injection. All subjects will be contacted by phone at day 14 to determine if there have been any adverse events and report their pain level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing primary total knee arthroplasty surgery 18-80.\n\nExclusion Criteria:\n\n* Patient on chronic anticoagulation\n* Allergy to local anesthetics, nsaids, or opioids\n* Patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post- operatively\n* Daily use of opioid for more than three weeks\n* Lack of patient cooperation'}, 'identificationModule': {'nctId': 'NCT02616367', 'briefTitle': 'Comparison of Comparison of Ropivacaine and Liposomal Bupivacaine for Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Comparison Between Ropivacaine and Liposomal Bupivacaine Periarticular Injections for Pain Relief After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '1503M66201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'liposomal bupivacaine Periarticular injection', 'description': 'Will consist of 100 mL (one syringe with 50 mL total: 40 mL 0.25% bupivacaine, 300 mcg epinephrine, 1 mL ketorolac, 2.5 mL morphine, 6.5 mL normal saline) (one syringe with 50 mL total: 20 mL liposomal bupivacaine 30 mL normal saline).', 'interventionNames': ['Drug: liposomal bupivacaine Periarticular injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine Periarticular Injection', 'description': 'Will consist of 100 mL (1 mL ketorolac, 2.5 mL morphine, 28.95 mL normal saline, 300 mcg of epinephrine, and 200 mg ropivacaine', 'interventionNames': ['Drug: Ropivacaine Periarticular Injection']}], 'interventions': [{'name': 'liposomal bupivacaine Periarticular injection', 'type': 'DRUG', 'otherNames': ['Exparel'], 'description': 'Liposomal bupivacaine used for a periarticular injection in the knee', 'armGroupLabels': ['liposomal bupivacaine Periarticular injection']}, {'name': 'Ropivacaine Periarticular Injection', 'type': 'DRUG', 'otherNames': ['Norapin'], 'description': 'Periarticular Injection for the knee with ropivacaine', 'armGroupLabels': ['Ropivacaine Periarticular Injection']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Roberto D Blanco', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}