search
Back to results

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

Primary Purpose

Hip Fractures, Perioperative Myocardial Ischemia

Status
Completed
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Continuous lumbar plexus (LP) block analgesia
Intravenous patient-controlled analgesia
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Continuous lumbar plexus (LP) block analgesia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Division de Anestesia - Pontificia Universidad Catolica de Chile
  • División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intravenous patient-controlled analgesia

Continuous lumbar plexus (LP) block analgesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2013
Last Updated
October 11, 2013
Sponsor
Pontificia Universidad Catolica de Chile
search

1. Study Identification

Unique Protocol Identification Number
NCT01961895
Brief Title
Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture
Official Title
Evaluation of the Effect of Perioperative Continuous Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Perioperative Myocardial Ischemia
Keywords
Continuous lumbar plexus (LP) block analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous patient-controlled analgesia
Arm Type
Active Comparator
Arm Description
Intravenous morphine solution 0.2 mg / ml in PCA mode without basal infusion, 1mg bolus demand and lockout of 8 minutes.
Arm Title
Continuous lumbar plexus (LP) block analgesia
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Continuous lumbar plexus (LP) block analgesia
Intervention Type
Drug
Intervention Name(s)
Intravenous patient-controlled analgesia
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias).
Time Frame
3 days
Title
hospital death
Time Frame
3 days
Title
Death at 30, 90 and 360 days after surgery
Time Frame
1 year
Title
Perioperative Pain Intensity, measured in numerical rating scale (NRS).
Time Frame
3 days
Title
Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..)
Time Frame
3 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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. 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.
Facility Information:
Facility Name
Division de Anestesia - Pontificia Universidad Catolica de Chile
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8330024
Country
Chile
Facility Name
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8330024
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
33238043
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs