Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-26 @ 10:03 AM
Study NCT ID:
NCT01344395
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2010-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Local Infiltration Analgesia Following Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D020910', 'term': 'Ketorolac'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-21', 'studyFirstSubmitDate': '2010-04-09', 'studyFirstSubmitQcDate': '2011-04-27', 'lastUpdatePostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': '24 hours postoperatively', 'description': 'Cummulative morphine comsumption postoperatively'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '24 hours postoperatively', 'description': 'Pain intensity measured on the visual analog scale (VAS) at rest and during walking'}, {'measure': 'Postoperative nausea', 'timeFrame': '24 hours postoperatively', 'description': 'Number of episodes of nausea measured on a 3 points rating scale (mild, moderate and severe)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Pain']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to evaluate if multiple postoperative administrations with a solution of ropivacaine, ketorolac and epinephrine into the operating field through a catheter would affect morphine consumption. Secondary end-points are pain intensity, side effects and length of stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for total hip arthroplasty\n* Patients \\> 18 years of age\n* Signed written informed consent\n* Spinal anaesthesia\n\nExclusion Criteria:\n\n* Allergy towards study drugs\n* Rheumatoid arthritis\n* Body Mass Index \\> 35 (severe obesity)\n* Pregnancy or nursing women\n* Regular opioid use\n* Patients who can not read or understand danish'}, 'identificationModule': {'nctId': 'NCT01344395', 'briefTitle': 'Use of Local Infiltration Analgesia Following Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Local Infiltration Analgesia in Total Hip Arthroplasty - Efficacy of Multiple Bolus Injections With Ropivacaine and Ketorolac', 'orgStudyIdInfo': {'id': '2009-016445-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RK-group', 'interventionNames': ['Drug: ropivacaine and ketorolac']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'K-group', 'interventionNames': ['Drug: Ketorolac']}], 'interventions': [{'name': 'ropivacaine and ketorolac', 'type': 'DRUG', 'description': 'The RK-group receives four intra-articular injections via catheter with a total volume of 40 ml (380 mg ropivacaine and 60 mg ketorolac) combined with 4 intravenous injections of saline during 24 hours postoperatively', 'armGroupLabels': ['RK-group']}, {'name': 'Ketorolac', 'type': 'DRUG', 'description': 'The K-group receives four intra-articular injections via catheter with a total volume of 40 ml saline combined with 4 intravenous injections of ketorolac (total 60 mg) during 24 hours postoperatively', 'armGroupLabels': ['K-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Kjeld Søballe, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundbeck Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}