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

Hip Fractures Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961895
• Other study ID #: Altermatt 09-148
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2013
• Last updated: October 11, 2013
• Start date: May 2010

Study information

• Verified date: October 2013
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review BoardChile: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Fractures, Bone
• Hip Fractures
• Myocardial Ischemia
• Perioperative Myocardial Ischemia

Intervention

Procedure:
• Continuous lumbar plexus (LP) block analgesia

Drug:
• Intravenous patient-controlled analgesia

Locations

Country	Name	City	State
Chile	División de Anestesia - Facultad de Medicina Pontificia Universidad Católica	Santiago	Región Metropolitana
Chile	Division de Anestesia - Pontificia Universidad Catolica de Chile	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias).		3 days	No
Secondary	hospital death		3 days	Yes
Secondary	Death at 30, 90 and 360 days after surgery		1 year	No
Secondary	Perioperative Pain Intensity, measured in numerical rating scale (NRS).		3 days	No
Secondary	Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..)		3 days	No