Evaluation of a Femoralis, n Femoralis and m Iliopsoas Tendon Sonoanatomy According to Age Groups in Children

February 16, 2024 updated by: Hande Gurbuz, Derince Training and Research Hospital
This study aims to examine the sonoanatomy of the inguinal region in children according to age groups.

Study Overview

Detailed Description

Regional anesthesia is frequently used in adults and children as part of multimodal analgesia or as a direct anesthesia method. Nowadays, these regional blocks can be applied more safely with the widespread use of ultrasound in daily clinical practice. Also, by identifying individual variations with ultrasound, the risk of block failure and possible complications has been minimized. Femoral nerve block and pericapsular nerve group block are now almost the first techniques used in hip and lower extremity surgeries or different indications. (1) Besides, these methods have become more advantageous in many aspects compared to spinal anesthesia in high-risk patients. However, to apply safe and successful regional anesthesia, both gross anatomy and sonoanatomy of the relevant region must be known well.

There are sufficient clinical and anatomical studies on these anesthesia methods applied in the inguinal region in adults, and there is no anatomical and anthropometric study in children. (2,3) However, well-known anatomic reference points for performing these blocks in adults may be different in children. (4) Therefore, with this study, we planned to develop appropriate anatomic reference points for these blocks in children by evaluating the relationship between sonography and inguinal region structures (such as distance, diameter measurement) in children's age groups.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yıldırım
      • Bursa, Yıldırım, Turkey, 16310
        • Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All pediatric patients within the predetermined age group

Description

Inclusion Criteria:

  • All pediatric patients

Exclusion Criteria:

  • a previous surgical history to the related area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants: 28 days - 12 month
inguinal sonoanatomy
ultrasonography to inguinal region
small children: 13 months - 36 months
inguinal sonoanatomy
ultrasonography to inguinal region
preschool age: 37 months - 72 months
inguinal sonoanatomy
ultrasonography to inguinal region
school age: 73 months - 9 years
inguinal sonoanatomy
ultrasonography to inguinal region
Preadolescant: >9 years - 12 years
inguinal sonoanatomy
ultrasonography to inguinal region
Adolescants: >12 years - 18 years
inguinal sonoanatomy
ultrasonography to inguinal region

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
femoral artery and femoral nerve distance (mm)
Time Frame: 1 hour
ultrasonographic measurements
1 hour
Body weight (gr)
Time Frame: 1 hour
measured at ward
1 hour
height (cm)
Time Frame: 1 hour
measured at ward
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Hande Gurbuz, Assoc. Prof., Bursa Yuksek Ihtisas Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2021

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 25, 2024

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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