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

Sponsor
Derince Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04860479
Collaborator
Kocaeli University (Other)
150
1
5.2
28.9

Study Details

Study Description

Brief Summary

This study aims to examine the sonoanatomy of the inguinal region in children according to age groups.

Condition or Disease Intervention/Treatment Phase
  • Device: ultrasound

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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of a Femoralis, n Femoralis and m Iliopsoas Tendon Sonoanatomy According to Age Groups in Children
Actual Study Start Date :
Apr 26, 2021
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Infants: 28 days - 12 month

inguinal sonoanatomy

Device: ultrasound
ultrasonography to inguinal region

small children: 13 months - 36 months

inguinal sonoanatomy

Device: ultrasound
ultrasonography to inguinal region

preschool age: 37 months - 72 months

inguinal sonoanatomy

Device: ultrasound
ultrasonography to inguinal region

school age: 73 months - 9 years

inguinal sonoanatomy

Device: ultrasound
ultrasonography to inguinal region

Preadolescant: >9 years - 12 years

inguinal sonoanatomy

Device: ultrasound
ultrasonography to inguinal region

Adolescants: >12 years - 18 years

inguinal sonoanatomy

Device: ultrasound
ultrasonography to inguinal region

Outcome Measures

Primary Outcome Measures

  1. femoral artery and femoral nerve distance (mm) [1 hour]

    ultrasonographic measurements

  2. Body weight (gr) [1 hour]

    measured at ward

  3. height (cm) [1 hour]

    measured at ward

Eligibility Criteria

Criteria

Ages Eligible for Study:
28 Days to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All pediatric patients
Exclusion Criteria:
  • a previous surgical history to the related area

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bursa Yuksek Ihtisas Training and Research Hospital Bursa Yıldırım Turkey 16310

Sponsors and Collaborators

  • Derince Training and Research Hospital
  • Kocaeli University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hande Gurbuz, Medical Doctor, Associate Professor, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT04860479
Other Study ID Numbers:
  • 2011-KAEK-25
First Posted:
Apr 27, 2021
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hande Gurbuz, Medical Doctor, Associate Professor, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2021