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

Pontificia Universidad Catolica de Chile

Status and phase: Completed; Phase 4

Conditions: Hip Fractures; Perioperative Myocardial Ischemia

Treatments: Drug: Intravenous patient-controlled analgesia; Procedure: Continuous lumbar plexus (LP) block analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01961895

Altermatt 09-148

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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31 participants in 2 patient groups

Intravenous patient-controlled analgesia

Active Comparator group

Description:

Intravenous morphine solution 0.2 mg / ml in PCA mode without basal infusion, 1mg bolus demand and lockout of 8 minutes.

Treatment:

Drug: Intravenous patient-controlled analgesia

Continuous lumbar plexus (LP) block analgesia

Experimental group

Description:

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

Treatment:

Procedure: Continuous lumbar plexus (LP) block analgesia