Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-31 @ 9:39 AM
Study NCT ID:
NCT01012232
Status:
COMPLETED
Last Update Posted:
2009-11-11
First Post:
2009-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-10', 'studyFirstSubmitDate': '2009-11-10', 'studyFirstSubmitQcDate': '2009-11-10', 'lastUpdatePostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': '32 hours postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'postoperative pain'], 'conditions': ['Postoperative Pain', 'Analgesic Efficacy']}, 'descriptionModule': {'briefSummary': 'In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at rest and with mobilization for 2 hours after injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for total knee arthroplasty\n* Able to give informed oral and written consent to participate\n\nExclusion Criteria:\n\n* Treatment with opioids or steroids, rheumatoid arthritis or other immunological diseases\n* History of stroke or any neurological or psychiatric disease potentially influencing pain perception (e.g. depression, diabetic neuropathy etc.)\n* Allergies to any of the drugs administered.'}, 'identificationModule': {'nctId': 'NCT01012232', 'briefTitle': 'Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration', 'organization': {'class': 'OTHER', 'fullName': 'Lundbeck Foundation'}, 'officialTitle': 'The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.', 'orgStudyIdInfo': {'id': 'H-D-2009-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'low volume local anesthetic', 'description': 'bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)', 'interventionNames': ['Drug: 10 mL ropivacaine 10 mg/mL']}, {'type': 'EXPERIMENTAL', 'label': 'high volume local anesthetic', 'description': 'bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)', 'interventionNames': ['Drug: 20 mL ropivacaine 5 mg/mL']}], 'interventions': [{'name': '20 mL ropivacaine 5 mg/mL', 'type': 'DRUG', 'armGroupLabels': ['high volume local anesthetic']}, {'name': '10 mL ropivacaine 10 mg/mL', 'type': 'DRUG', 'armGroupLabels': ['low volume local anesthetic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Lundbeck Centre for fast-track hip and knee arthroplasty', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lundbeck Foundation', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Lasse Andersen', 'oldOrganization': 'The Lundbeck Centre for Fast-track Hip and Knee Arthroplasty'}}}}