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Clinical Trials/NCT01961895
NCT01961895
Completed
Phase 4

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

Pontificia Universidad Catolica de Chile2 sites in 1 country31 target enrollmentMay 2010

Overview

Phase
Phase 4
Intervention
Intravenous patient-controlled analgesia
Conditions
Hip Fractures
Sponsor
Pontificia Universidad Catolica de Chile
Enrollment
31
Locations
2
Primary Endpoint
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.
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
May 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

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.

Intervention: Intravenous patient-controlled 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

Intervention: Continuous lumbar plexus (LP) block analgesia

Outcomes

Primary Outcomes

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.

Time Frame: 3 days

Secondary Outcomes

  • 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)

Study Sites (2)

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