Clinical trial NCT01961895: Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Fractures
Perioperative Myocardial Ischemia
Keywords: Continuous lumbar plexus (LP) block analgesia
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 3 days
Secondary outcomes:
measure: Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias).
timeFrame: 3 days
measure: hospital death
timeFrame: 3 days
measure: Death at 30, 90 and 360 days after surgery
timeFrame: 1 year
measure: Perioperative Pain Intensity, measured in numerical rating scale (NRS).
timeFrame: 3 days
measure: Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..)
timeFrame: 3 days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Division de Anestesia - Pontificia Universidad Catolica de Chile
state: Region Metropolitana
city: Santiago
country: Chile
facility: División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
state: Región Metropolitana
Study officials:
References:
citation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.