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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Effect of Perioperative Continuous Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture.

Conditions
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Hip Fractures, Perioperative Myocardial Ischemia

Intervention / Treatment
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* Procedure: Continuous lumbar plexus (LP) block analgesia
* Drug: Intravenous patient-controlled analgesia


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous patient-controlled analgesia<br>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<br> <br> |
| Experimental: Continuous lumbar plexus (LP) block analgesia<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias). |  | 3 days | 
| hospital death |  | 3 days | 
| Death at 30, 90 and 360 days after surgery |  | 1 year | 
| Perioperative Pain Intensity, measured in numerical rating scale (NRS). |  | 3 days | 
| Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..) |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous lumbar plexus (LP) block analgesia