NCT06026150

Brief Summary

The goal of this observational study is to learn about the relative position of femoral nerve in relation to the femoral artery in patients scheduled for femoral fractures using ultrasound scanning. The classical description of femoral nerve is that it lies immediately near to artery, but it is not always true. The nerve lies at a varying distance from the artery. The main question it aims to answer are: • Is the age sex and Body Mass Index affect the relationship between femoral artery and nerve?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

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

April 10, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

4.6 years

First QC Date

August 7, 2023

Last Update Submit

September 2, 2023

Conditions

Keywords

femoral fractureUltrasound anatomy of femoral nerve

Outcome Measures

Primary Outcomes (1)

  • Variability of anatomical position of Femoral Nerve with respect to Femoral artery - effect of age, sex and BMI

    After positioning the patients with femoral fracture, ultrasound scanning of femoral nerve is done and the femoral nerve and arteries are identified. The distance between the femoral artery and nerve are measured using ultrasound.

    From the time the patient is positioned for ultrasound scanning to obtain a clear image of the femoral nerve until the measurement of the distance between the femoral nerve and artery is completed, assessed over a period of up to 6 hours.

Interventions

ultrasound scanning of inguinal region is done in femoral fracture patient to identify femoral artery and nerve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

femoral fracture patients admitted in Rashid hospital and trauma centre Dubai

You may qualify if:

  • above the age of 18 coming for fixation of femoral fracture

You may not qualify if:

  • below the age of 18
  • patient not willing to participate
  • patients with neurological illness that hinders from giving a valid consent
  • patients with local pathology at inguinal region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Fanara B, Christophe JL, Boillot A, Tatu L, Jochum D, Henri Y, Berthier F, Samain E. Ultrasound guidance of needle tip position for femoral nerve blockade: an observational study. Eur J Anaesthesiol. 2014 Jan;31(1):23-9. doi: 10.1097/01.EJA.0000435016.83813.aa.

    PMID: 24145804BACKGROUND
  • Fingerman M, Benonis JG, Martin G. A practical guide to commonly performed ultrasound-guided peripheral-nerve blocks. Curr Opin Anaesthesiol. 2009 Oct;22(5):600-7. doi: 10.1097/ACO.0b013e32832f7643.

    PMID: 19606024BACKGROUND
  • Baker MD, Gullett JP. Ultrasound-Guided Femoral Nerve Blocks. Pediatr Emerg Care. 2015 Dec;31(12):864-8; quiz 869-71. doi: 10.1097/PEC.0000000000000634.

    PMID: 26626896BACKGROUND
  • Szucs S, Morau D, Iohom G. Femoral nerve blockade. Med Ultrason. 2010 Jun;12(2):139-44.

    PMID: 21173942BACKGROUND

Related Links

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Specialist, Dept of Anesthesiology

Study Record Dates

First Submitted

August 7, 2023

First Posted

September 6, 2023

Study Start

April 10, 2016

Primary Completion

November 30, 2020

Study Completion

August 15, 2021

Last Updated

September 6, 2023

Record last verified: 2023-09