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

October 11, 2013 updated by: Pontificia Universidad Catolica de Chile

Evaluation of the Effect of Perioperative Continuous 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8330024
        • Division de Anestesia - Pontificia Universidad Catolica de Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8330024
        • División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Intravenous patient-controlled analgesia
Experimental: 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
Procedure: Continuous lumbar plexus (LP) block analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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.
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias).
Time Frame: 3 days
3 days
hospital death
Time Frame: 3 days
3 days
Death at 30, 90 and 360 days after surgery
Time Frame: 1 year
1 year
Perioperative Pain Intensity, measured in numerical rating scale (NRS).
Time Frame: 3 days
3 days
Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..)
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Estimate)

October 14, 2013

Last Update Submitted That Met QC Criteria

October 11, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Altermatt 09-148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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