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Trial record 95 of 761 for:    region | Chile

Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture

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ClinicalTrials.gov Identifier: NCT01961895
Recruitment Status : Completed
First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hip Fractures Perioperative Myocardial Ischemia Procedure: Continuous lumbar plexus (LP) block analgesia Drug: Intravenous patient-controlled analgesia Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Perioperative Continuous Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture.
Study Start Date : May 2010
Actual Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intravenous patient-controlled analgesia
Intravenous morphine solution 0.2 mg / ml in PCA mode without basal infusion, 1mg bolus demand and lockout of 8 minutes.
Drug: Intravenous patient-controlled analgesia
Experimental: Continuous lumbar plexus (LP) block analgesia

Continuous lumbar plexus (LP) block analgesia. Continuous infusion of a solution of 0.1% bupivacaine in PCA mode, programmed at 8 ml / h.

Rescue bolus 5 ml and 30 minutes lockout

Procedure: Continuous lumbar plexus (LP) block analgesia



Primary Outcome Measures :
  1. 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. [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias). [ Time Frame: 3 days ]
  2. hospital death [ Time Frame: 3 days ]
  3. Death at 30, 90 and 360 days after surgery [ Time Frame: 1 year ]
  4. Perioperative Pain Intensity, measured in numerical rating scale (NRS). [ Time Frame: 3 days ]
  5. Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..) [ Time Frame: 3 days ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hip fracture within 48 hours of evolution
  • Known coronary artery disease:

Previous 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

  • Patients with at least two of the risk factors for coronary heart disease as defined by Wallace (1998)

Exclusion Criteria:

  • Patients receiving orthopedic treatment.
  • Patients with coagulopathy, clinic or laboratory.
  • Patients with sepsis or infection of the catheter insertion site of lumbar plexus.
  • Patients with neurological diseases evolving.
  • Patients disoriented, or dementia.
  • CKD stage IV National Kidney Foundation (2)
  • Glomerular filtration rate between 15 and 29 mL/min/1, 73 m2
  • Patients unable to use the Numeric Rating Scale (NRS) to assess pain.
  • Patients with non-sinus rhythm or conduction abnormalities (right bundle branch block or left, atrioventricular block) in the admission ECG
  • Patients with pacemaker.
  • Enrolled patients with acute coronary syndrome or decompensated cardiovascular disease at entry.
  • Allergy to any of the drugs of the protocol.
  • Inability to understand or unaided sign informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961895


Locations
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Chile
Division de Anestesia - Pontificia Universidad Catolica de Chile
Santiago, Region Metropolitana, Chile, 8330024
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
Santiago, Región Metropolitana, Chile, 8330024
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01961895     History of Changes
Other Study ID Numbers: Altermatt 09-148
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013

Keywords provided by Pontificia Universidad Catolica de Chile:
Continuous lumbar plexus (LP) block analgesia

Additional relevant MeSH terms:
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Fractures, Bone
Ischemia
Hip Fractures
Myocardial Ischemia
Coronary Artery Disease
Wounds and Injuries
Pathologic Processes
Femoral Fractures
Hip Injuries
Leg Injuries
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases