Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-07 @ 6:51 AM
Study NCT ID:
NCT01961895
Status:
COMPLETED
Last Update Posted:
2013-10-14
First Post:
2013-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-11', 'studyFirstSubmitDate': '2013-10-10', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject.', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias).', 'timeFrame': '3 days'}, {'measure': 'hospital death', 'timeFrame': '3 days'}, {'measure': 'Death at 30, 90 and 360 days after surgery', 'timeFrame': '1 year'}, {'measure': 'Perioperative Pain Intensity, measured in numerical rating scale (NRS).', 'timeFrame': '3 days'}, {'measure': 'Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..)', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Continuous lumbar plexus (LP) block analgesia'], 'conditions': ['Hip Fractures', 'Perioperative Myocardial Ischemia']}, 'referencesModule': {'references': [{'pmid': '33238043', 'type': 'DERIVED', 'citation': 'Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hip fracture within 48 hours of evolution\n* Known coronary artery disease:\n\nPrevious myocardial infarction Chronic stable angina Atypical angina with positive exercise test for coronary flow failure. Evidence of coronary artery disease with ultrasound, scintigraphic or angiographic compatible\n\n* Patients with at least two of the risk factors for coronary heart disease as defined by Wallace (1998)\n\nExclusion Criteria:\n\n* Patients receiving orthopedic treatment.\n* Patients with coagulopathy, clinic or laboratory.\n* Patients with sepsis or infection of the catheter insertion site of lumbar plexus.\n* Patients with neurological diseases evolving.\n* Patients disoriented, or dementia.\n* CKD stage IV National Kidney Foundation (2)\n* Glomerular filtration rate between 15 and 29 mL/min/1, 73 m2\n* Patients unable to use the Numeric Rating Scale (NRS) to assess pain.\n* Patients with non-sinus rhythm or conduction abnormalities (right bundle branch block or left, atrioventricular block) in the admission ECG\n* Patients with pacemaker.\n* Enrolled patients with acute coronary syndrome or decompensated cardiovascular disease at entry.\n* Allergy to any of the drugs of the protocol.\n* Inability to understand or unaided sign informed consent.'}, 'identificationModule': {'nctId': 'NCT01961895', 'briefTitle': 'Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Evaluation of the Effect of Perioperative Continuous Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture.', 'orgStudyIdInfo': {'id': 'Altermatt 09-148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous patient-controlled analgesia', 'description': 'Intravenous morphine solution 0.2 mg / ml in PCA mode without basal infusion, 1mg bolus demand and lockout of 8 minutes.', 'interventionNames': ['Drug: Intravenous patient-controlled analgesia']}, {'type': 'EXPERIMENTAL', 'label': 'Continuous lumbar plexus (LP) block analgesia', 'description': 'Continuous lumbar plexus (LP) block analgesia. Continuous infusion of a solution of 0.1% bupivacaine in PCA mode, programmed at 8 ml / h.\n\nRescue bolus 5 ml and 30 minutes lockout', 'interventionNames': ['Procedure: Continuous lumbar plexus (LP) block analgesia']}], 'interventions': [{'name': 'Continuous lumbar plexus (LP) block analgesia', 'type': 'PROCEDURE', 'armGroupLabels': ['Continuous lumbar plexus (LP) block analgesia']}, {'name': 'Intravenous patient-controlled analgesia', 'type': 'DRUG', 'armGroupLabels': ['Intravenous patient-controlled analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8330024', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Division de Anestesia - Pontificia Universidad Catolica de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8330024', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'División de Anestesia - Facultad de Medicina Pontificia Universidad Católica', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}