NCT04975386

Brief Summary

Nerve blocks applied with neuraxial anesthesia and ultrasonography are used for many operations today. Neuraxial blocks cause varying degrees of decrease in the blood pressure level of the patients. Peripheral blocks may be preferred to avoid the cardiac effects of the neuraxial anesthesia method.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Status
unknown

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

First Submitted

Initial submission to the registry

July 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

July 29, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 14, 2021

Last Update Submit

July 23, 2021

Conditions

Femur FractureSpinal AnesthesiaLumbar Plexus Block

Outcome Measures

Primary Outcomes (1)

  • Ejection fraction

    Ejection fraction (EF) measurement will be made with Simpson's method and fractional shortening method.

    peroperative

Secondary Outcomes (5)

  • intraoperative blood pressure monitoring

    peroperative

  • cardiac diastolic dysfunction

    peroperative

  • Entropy

    peroperative

  • sedative drug

    intraoperative

  • ramsey sedation scale

    intraoperative

Study Arms (2)

spinal anesthesia

ACTIVE COMPARATOR
Device: Transthoracic echocardiogram

lumbar plexus+sacral plexus block

ACTIVE COMPARATOR
Device: Transthoracic echocardiogram

Interventions

Transthoracic echocardiogramDEVICE

Transthoracic echocardiogram will be performed before the operation and at certain time intervals during the operation.

lumbar plexus+sacral plexus blockspinal anesthesia

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • American Society of Anesthesiologist Score I-IV

You may not qualify if:

  • Local anesthetic allergy
  • Bleeding disorder
  • Mental disorder
  • Allergy to drugs used
  • Body mass index above 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Femoral Fractures

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Durdu M.D Kahraman Yıldız

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Korgün Ökmen, Assoc. PhD.

CONTACT

+905057081021korgunokmen@gmail.com

Korgün M.D Ökmen, Assoc. PhD.

CONTACT

+905057081021korgunokmen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator ,Assoc. PhD. M.D.

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 23, 2021

Study Start

July 29, 2021

Primary Completion

July 29, 2022

Study Completion

August 15, 2022

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share