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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01961895
Enrollment
31
Registered
2013-10-14
Start date
2010-05-31
Completion date
Unknown
Last updated
2013-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures, Perioperative Myocardial Ischemia

Keywords

Continuous lumbar plexus (LP) block analgesia

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.

Interventions

PROCEDUREContinuous lumbar plexus (LP) block analgesia

Sponsors

Pontificia Universidad Catolica de Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias).3 days
hospital death3 days
Death at 30, 90 and 360 days after surgery1 year
Perioperative Pain Intensity, measured in numerical rating scale (NRS).3 days
Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..)3 days

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026