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

Phase 4

Completed

• Conditions: Hip Fractures; Perioperative Myocardial Ischemia
• Interventions: Drug: Intravenous patient-controlled analgesia; Procedure: Continuous lumbar plexus (LP) block analgesia

• Registration Number: NCT01961895
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-05
• Status Verified: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-11
• Last Update Submitted: 2013-10-11
• Study First Posted: 2013-10-14
• Last Update Posted: 2013-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous patient-controlled analgesia	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.
Continuous lumbar plexus (LP) block analgesia	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

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

Division de Anestesia - Pontificia Universidad Catolica de Chile; 🇨🇱 Santiago, Region Metropolitana, Chile

División de Anestesia - Facultad de Medicina Pontificia Universidad Católica; 🇨🇱 Santiago, Región Metropolitana, Chile