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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04860479
Other study ID # 2011-KAEK-25
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 26, 2021
Est. completion date January 25, 2024

Study information

Verified date February 2024
Source Derince Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date January 25, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 28 Days to 18 Years
Eligibility Inclusion Criteria: - All pediatric patients Exclusion Criteria: - a previous surgical history to the related area

Study Design


Intervention

Device:
ultrasound
ultrasonography to inguinal region

Locations

Country Name City State
Turkey Bursa Yuksek Ihtisas Training and Research Hospital Bursa Yildirim

Sponsors (2)

Lead Sponsor Collaborator
Derince Training and Research Hospital Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary femoral artery and femoral nerve distance (mm) ultrasonographic measurements 1 hour
Primary Body weight (gr) measured at ward 1 hour
Primary height (cm) measured at ward 1 hour
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