- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04860479
Evaluation of a Femoralis, n Femoralis and m Iliopsoas Tendon Sonoanatomy According to Age Groups in Children
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Yıldırım
-
Bursa, Yıldırım, Turkey, 16310
- Bursa Yuksek Ihtisas Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All pediatric patients
Exclusion Criteria:
- a previous surgical history to the related area
Study Plan
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
Collaborators
Investigators
- Principal Investigator: Hande Gurbuz, Assoc. Prof., Bursa Yuksek Ihtisas Training and Research Hospital
Publications and helpful links
General Publications
- Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Orozco S, Munoz D, Jaramillo S, Herrera AM. Pediatric use of Pericapsular Nerve Group (PENG) block for hip surgical procedures. J Clin Anesth. 2019 Nov;57:143-144. doi: 10.1016/j.jclinane.2019.04.010. Epub 2019 Apr 22. No abstract available.
- Frkovic V, Warmlander SK, Petaros A, Spanjol-Pandelo I, Azman J. Finger width as a measure of femoral block puncture site: an ultrasonographic anatomical-anthropometric study. J Clin Anesth. 2015 Nov;27(7):553-7. doi: 10.1016/j.jclinane.2015.07.015. Epub 2015 Aug 31.
- Yoshimura M, Nakanishi T, Sakamoto S, Toriumi T. Age is a predictive factor in the femoral nerve positioning: an anatomical ultrasound study. J Anesth. 2018 Oct;32(5):777-780. doi: 10.1007/s00540-018-2544-2. Epub 2018 Aug 21.
- Vloka JD, Hadzic A, Drobnik L, Ernest A, Reiss W, Thys DM. Anatomical landmarks for femoral nerve block: a comparison of four needle insertion sites. Anesth Analg. 1999 Dec;89(6):1467-70. doi: 10.1097/00000539-199912000-00028.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-KAEK-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Pediatrics
-
Vanderbilt UniversityRita & Alex Hillman FoundationCompleted
-
Fundación para el Fomento de la Investigación Sanitaria...CompletedPediatrics | EchocardiographySpain
-
University of FloridaFogarty International Center of the National Institute of HealthRecruitingTelemedicine | PediatricsHaiti
-
University of CalgaryCompletedHealthy | PediatricsCanada
-
University of CalgaryCompleted
-
Sisli Hamidiye Etfal Training and Research HospitalCompletedPediatrics | Anesthesiology
-
Kasr El Aini HospitalCompleted
-
Johns Hopkins UniversityThe Thomas Wilson Sanitarium for Children of Baltimore CityTerminated
-
Samsung Medical CenterCompletedPediatricsKorea, Republic of
-
Yonsei UniversityUnknown
Clinical Trials on ultrasound
-
Ahram Canadian UniversityCompletedCarpal Tunnel Syndrome | Median Neuropathy, Carpal TunnelEgypt
-
Eskisehir Osmangazi UniversityCompletedCarpal Tunnel Syndrome
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Withdrawn
-
Cairo UniversityUnknown
-
Ohio State University Comprehensive Cancer CenterWithdrawn
-
Oregon Health and Science UniversityRecruiting
-
Yale UniversityCompletedPneumonia | Pulmonary Edema | DyspneaUnited States
-
Odense University HospitalEnrolling by invitationThoracic Ultrasound | Fibrosing Interstitial Lung DiseasesDenmark
-
Bursa Yüksek İhtisas Education and Research HospitalCompletedShoulder Impingement Syndrome | Shoulder PainTurkey
-
John PelleritoGeneral ElectricActive, not recruiting