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Completed

NCT Number: NCT01961895

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

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.

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Perioperative Myocardial Ischemia Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division de Anestesia - Pontificia Universidad Catolica de Chile, Santiago, Santiago Metropolitan, Chile

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous lumbar plexus (LP) block analgesia

Procedure

Intravenous patient-controlled analgesia

Drug

Primary outcomes

  1. 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

  1. Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias).

    Time frame: 3 days

  2. hospital death

    Time frame: 3 days

  3. Death at 30, 90 and 360 days after surgery

    Time frame: 1 year

  4. Perioperative Pain Intensity, measured in numerical rating scale (NRS).

    Time frame: 3 days

  5. Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..)

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
First posted
Oct 14, 2013
Registry last updated
Oct 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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