Anatomic AbnormalityNCT04860479
Evaluation of a Femoralis, n Femoralis and m Iliopsoas Tendon Sonoanatomy According to Age Groups in Children
An observational study of Anatomic Abnormality and Anatomy, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the sonoanatomy of the inguinal region in children according to age groups. Read more about this study
- Who is it for?
- Ages 28 days to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anatomic Abnormality, Anatomy, Pediatrics
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Apr 2021to 25 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All pediatric patients within the predetermined age group
Who may be able to join
- All pediatric patients
Who cannot join
- a previous surgical history to the related area
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Yıldırım, 16310
About this study
This study aims to examine the sonoanatomy of the inguinal region in children according to age groups.
Read the 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.
- Conditions
- Anatomic Abnormality, Anatomy, Pediatrics, Anatomic Landmarks, Anthropometry
- Being tested
- ultrasound
- Keywords
- sonoanatomy, pediatrics, inguinal region, variation, anatomy, PENG, femoral nerve, regional anesthesia, femoral artery
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
ultrasonography to inguinal region
| Study group | Role | What they receive |
|---|---|---|
| Infants: 28 days - 12 month | inguinal sonoanatomy Receives: Device: ultrasound | |
| small children: 13 months - 36 months | inguinal sonoanatomy Receives: Device: ultrasound | |
| preschool age: 37 months - 72 months | inguinal sonoanatomy Receives: Device: ultrasound | |
| school age: 73 months - 9 years | inguinal sonoanatomy Receives: Device: ultrasound | |
| Preadolescant: >9 years - 12 years | inguinal sonoanatomy Receives: Device: ultrasound | |
| Adolescants: >12 years - 18 years | inguinal sonoanatomy Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
femoral artery and femoral nerve distance (mm)
ultrasonographic measurements
Measured: 1 hour
Body weight (gr)
measured at ward
Measured: 1 hour
height (cm)
measured at ward
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start26 Apr 2021
- Primary completion1 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anatomic AbnormalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kocaeli University
- Responsible party
- Principal investigator, Hande Gurbuz, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Hande Gurbuz, Assoc. Prof., Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860479
- Sponsor's protocol ID
- 2011-KAEK-25
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30063657Orozco 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.
PubMed 31022606Frkovic 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.
PubMed 26337562Vloka 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.
PubMed 10589630Yoshimura 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.
PubMed 30132074Gurbuz H, Colak T. Evaluation of inguinal sonoanatomy regarding pericapsular nerve group (PENG) block in children: the relation of femoral artery, femoral nerve, lateral femoral cutaneous nerve and iliopsoas notch. BMC Anesthesiol. 2025 Mar 31;25(1):144. doi: 10.1186/s12871-025-03020-2.
PubMed 40165082
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Femoralis, n Femoralis and m Iliopsoas Tendon Sonoanatomy According to Age Groups in Children
- ClinicalTrials.gov ID
- NCT04860479
- Acronym / sponsor ID
- 2011-KAEK-25
- Conditions
- Anatomic Abnormality, Anatomy, Pediatrics, Anatomic Landmarks, Anthropometry
- Keywords
- sonoanatomy, pediatrics, inguinal region, variation, anatomy, PENG, femoral nerve, regional anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Collaborators
- Kocaeli University
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine the sonoanatomy of the inguinal region in children according to age groups.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Infants: 28 days - 12 month | – | Device: ultrasoundinguinal sonoanatomy |
| small children: 13 months - 36 months | – | Device: ultrasoundinguinal sonoanatomy |
| preschool age: 37 months - 72 months | – | Device: ultrasoundinguinal sonoanatomy |
| school age: 73 months - 9 years | – | Device: ultrasoundinguinal sonoanatomy |
| Preadolescant: >9 years - 12 years | – | Device: ultrasoundinguinal sonoanatomy |
| Adolescants: >12 years - 18 years | – | Device: ultrasoundinguinal sonoanatomy |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All pediatric patients within the predetermined age group
Key inclusion criteria (1 listed)
- All pediatric patients
Key exclusion criteria (1 listed)
- a previous surgical history to the related area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundultrasonography to inguinal region | Device | Adolescants: >12 years - 18 years, Infants: 28 days - 12 month, Preadolescant: >9 years - 12 years, preschool age: 37 months - 72 months, school age: 73 months - 9 years, small children: 13 months - 36 months |
Primary outcome
femoral artery and femoral nerve distance (mm)
Time frame: 1 hour
ultrasonographic measurements
Body weight (gr)
Time frame: 1 hour
measured at ward
height (cm)
Time frame: 1 hour
measured at ward
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 30063657Giron-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.
- Results publication: PubMed 31022606Orozco 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.
- Results publication: PubMed 26337562Frkovic 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.
- Results publication: PubMed 10589630Vloka 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.
- Results publication: PubMed 30132074Yoshimura 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.
- Derived from this study: PubMed 40165082Gurbuz H, Colak T. Evaluation of inguinal sonoanatomy regarding pericapsular nerve group (PENG) block in children: the relation of femoral artery, femoral nerve, lateral femoral cutaneous nerve and iliopsoas notch. BMC Anesthesiol. 2025 Mar 31;25(1):144. doi: 10.1186/s12871-025-03020-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hande Gurbuz, Assoc. Prof. principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomic Abnormality and Anatomy, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
femoral artery and femoral nerve distance (mm) (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860479, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.