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

NCT ID: NCT01961895

Last Updated: 2013-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Fractures Perioperative Myocardial Ischemia

Keywords

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Continuous lumbar plexus (LP) block analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Intravenous patient-controlled analgesia

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Continuous lumbar plexus (LP) block analgesia

Intervention Type PROCEDURE

Interventions

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Continuous lumbar plexus (LP) block analgesia

Intervention Type PROCEDURE

Intravenous patient-controlled analgesia

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division de Anestesia - Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, Chile

Site Status

División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

References

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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.

Reference Type DERIVED
PMID: 33238043 (View on PubMed)

Other Identifiers

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Altermatt 09-148

Identifier Type: -

Identifier Source: org_study_id