Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-21 @ 1:51 AM
Study NCT ID:
NCT02863120
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2016-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}, {'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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2016-08-08', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay (LOS, in days)', 'timeFrame': 'Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days'}, {'measure': 'Time to ambulation (in hours)', 'timeFrame': '2-6 hours'}], 'secondaryOutcomes': [{'measure': 'Pain as assessed by visual analog scale (VAS) on postoperative day 0', 'timeFrame': '6 hours', 'description': 'Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5'}, {'measure': 'Pain as assessed by visual analog scale (VAS) on postoperative day 1', 'timeFrame': '24 hours', 'description': 'Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5'}, {'measure': 'Pain as assessed by visual analog scale (VAS) on postoperative day 2', 'timeFrame': '48 hours', 'description': 'Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5'}, {'measure': 'Pain as assessed by visual analog scale (VAS) on postoperative day 3', 'timeFrame': '72 hours', 'description': 'Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5'}, {'measure': 'Pain as assessed by visual analog scale (VAS) on postoperative day 4', 'timeFrame': '96 hours', 'description': 'Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5'}, {'measure': 'Pain as assessed by visual analog scale (VAS) on postoperative day 5', 'timeFrame': '120 hours', 'description': 'Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5'}, {'measure': 'Opioid consumption in oral morphine equivalents (OMEs, in milligrams)', 'timeFrame': 'Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days.'}, {'measure': 'Postoperative complications and adverse events', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bupivacaine', 'Osteoarthritis', 'Arthritis', 'Joint Diseases', 'Ropivacaine', 'Anesthetics, Local', 'Anesthetics'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief. The goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or non-pregnant female between the ages of 18-65\n* Patients willing and able to sign the informed consent\n* Patients able to comply with follow-up requirements including self-evaluations\n* Patients requiring a primary total knee replacement\n* Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis\n\nExclusion Criteria:\n\n* Revision total knee arthroplasty\n* Bilateral total knee arthroplasty\n* Patients with inflammatory arthritis\n* Patients with a body mass index (BMI) \\> 40\n* Allergy to ropivacaine, bupivacaine, or other local anesthetic agents\n* Current use of opioid drugs\n* Patients with a history of total or unicompartmental reconstruction of the affected joint\n* Patients that have had a high tibial osteotomy or femoral osteotomy\n* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels\n* Patients with a systemic or metabolic disorder leading to progressive bone deterioration\n* Patients that are immunologically compromised, or receiving chronic steroids (\\>30 days), excluding inhalers\n* Patients' bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis\n* Patients with knee fusion to the affected joint\n* Patients with an active or suspected latent infection in or about the knee joint\n* Patients that are prisoners"}, 'identificationModule': {'nctId': 'NCT02863120', 'briefTitle': 'Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Texas Orthopaedics, Sports and Rehabilitation Associates'}, 'officialTitle': 'Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'TG-EXP-160402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liposomal bupivacaine', 'description': 'Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants', 'interventionNames': ['Drug: liposomal bupivacaine', 'Drug: bupivacaine HCl', 'Drug: Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adductor canal and tibial nerve block', 'description': 'Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour', 'interventionNames': ['Drug: bupivacaine HCl', 'Drug: Ropivacaine']}], 'interventions': [{'name': 'liposomal bupivacaine', 'type': 'DRUG', 'otherNames': ['Exparel'], 'armGroupLabels': ['Liposomal bupivacaine']}, {'name': 'bupivacaine HCl', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'armGroupLabels': ['Adductor canal and tibial nerve block', 'Liposomal bupivacaine']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Naropin'], 'armGroupLabels': ['Adductor canal and tibial nerve block']}, {'name': 'Saline', 'type': 'DRUG', 'armGroupLabels': ['Liposomal bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Orthopedics', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Tyler D Goldberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Orthopedics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Orthopaedics, Sports and Rehabilitation Associates', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}