NCT01961895

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
Last Updated

October 14, 2013

Status Verified

October 1, 2013

Enrollment Period

2 years

First QC Date

October 10, 2013

Last Update Submit

October 11, 2013

Conditions

Hip FracturesPerioperative Myocardial Ischemia

Keywords

Continuous lumbar plexus (LP) block analgesia

Outcome Measures

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.

    3 days

Secondary Outcomes (5)

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

    3 days

  • hospital death

    3 days

  • Death at 30, 90 and 360 days after surgery

    1 year

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

    3 days

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

    3 days

Study Arms (2)

Intravenous patient-controlled analgesia

ACTIVE COMPARATOR

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

Continuous lumbar plexus (LP) block analgesia

EXPERIMENTAL

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

Interventions

Continuous lumbar plexus (LP) block analgesiaPROCEDURE
Continuous lumbar plexus (LP) block analgesia
Intravenous patient-controlled analgesiaDRUG
Intravenous patient-controlled analgesia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Division de Anestesia - Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

Location

División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Santiago, Santiago Metropolitan, 8330024, Chile

Location

Related Publications (1)

  • 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.

    PMID: 33238043DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 14, 2013

Study Start

May 1, 2010

Primary Completion

May 1, 2012

Last Updated

October 14, 2013

Record last verified: 2013-10

Locations

CL(2)