Learning CurveNCT06708598
Learning Curve of Ultrasound-Guided Suprainguinal Fascia Iliaca Block: A Prospective Observational Study
An observational study of Learning Curve and Suprainguinal Fasya Iliaca Block, run by Senay Canikli at 1 site in Turkey (Türkiye).
Trial summary
Competence in ultrasound-guided regional anesthesia (UGRA) requires practitioners to acquire cognitive and technical skills. Various difficulties have been identified in anesthesia residents' learning UGRA skills. Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Learning Curve, Suprainguinal Fasya Iliaca Block, Ultrasound-guided Regional Anesthesia (UGRA)
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2025to 10 Jun 2025
- 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 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Anesthesia residents with less than 2 years of anesthesia experience who have never performed a SIFIB before.
Who may be able to join
- Anesthesia residents with less than 2 years of anesthesia experience who have never performed a SIFIB before
Who cannot join
- Having previously performed a SIFIB
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SAMSUN UNIVERSITY Samsun Training and research hospital
Samsun, Ilkadım, 55025
About this study
Competence in ultrasound-guided regional anesthesia (UGRA) requires practitioners to acquire cognitive and technical skills. Various difficulties have been identified in anesthesia residents' learning UGRA skills. There is currently no approved UGRA curriculum for residents, and the level of UGRA proficiency achieved during residency may vary significantly. However, no specific training criteria have been defined for this block. It is important to establish criteria to evaluate the adequacy of education.
Read the detailed description
Compared to other nerve localization techniques, the benefits of UGRA include higher nerve block success rates, faster onset times, reduced local anesthetic volumes, and a lower risk of local anesthetic-related complications. Most experts now consider ultrasound guidance as the standard of care for peripheral nerve blocks. Successfully performing a UGRA procedure requires a triad of three distinct but interrelated skills: image acquisition, anatomical interpretation, and hand-eye coordination.
In our clinic, we routinely perform various nerve block techniques under ultrasound guidance during the perioperative period, both for postoperative analgesia and as a primary anesthetic method. Specifically, in our clinic, the suprainguinal fascia iliaca block (SIFIB) is routinely applied for postoperative analgesia, particularly in orthopedic cases. Before performing a nerve block procedure, resident doctors in our clinic undergo standard training and subsequently perform blocks under the supervision and support of experienced specialists and academicians.
What is being measured
The primary outcome is the main question the study is designed to answer.
Block success
"Additionally, to evaluate the success of the procedure more objectively, the following parameters will be assessed using a 5-point Likert scale (1: Very low, 2: Low, 3: Moderate, 4: High, 5: Very high). For the procedure to be considered successful, a score of 4 must be obtained for each parameter. These parameters include:
- Placement of the ultrasound probe
- Visualization of anatomical structures (muscle, bone, fascia, vessels)
- Optimization of needle localization
- Spread of the drug beneath the iliac fascia"
Measured: 20 minute
Secondary outcomes (1)
Block performance time
The block performance times of each practitioner will be recorded, and the average performance time will be calculated.
Measured: 20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start20 Jan 2025
- Primary completion30 May 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Learning CurveStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senay Canikli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Senay Canikli, Samsun University
- Investigators
- Senay Canikli Adıgüzel, Study director, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708598
- Sponsor's protocol ID
- GOKAEK 2024/21/6
- Status last verified
- Jun 2025
- First submitted
- 24 Nov 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data can be shared upon appropriate request after the study is completed.
Publications
Dang D, Kamal M, Kumar M, Paliwal B, Nayyar A, Bhatia P, Singariya G. Comparison of human cadaver and blue phantom for teaching ultrasound-guided regional anesthesia to novice postgraduate students of anesthesiology: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2024 Apr-Jun;40(2):276-282. doi: 10.4103/joacp.joacp_234_22. Epub 2024 May 16.
PubMed 38919433Kim TE, Tsui BCH. Simulation-based ultrasound-guided regional anesthesia curriculum for anesthesiology residents. Korean J Anesthesiol. 2019 Feb;72(1):13-23. doi: 10.4097/kja.d.18.00317. Epub 2018 Nov 27.
PubMed 30481945Rossetti M, Allgower D, Hell K. [Azygoportal interruption, fundoplication and vagotomy in hemorrhagic esophageal varices]. Helv Chir Acta. 1977 Oct;44(4):481-4. German.
PubMed 309462
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve of Ultrasound-Guided Suprainguinal Fascia Iliaca Block: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06708598
- Acronym / sponsor ID
- GOKAEK 2024/21/6
- Conditions
- Learning Curve, Suprainguinal Fasya Iliaca Block, Ultrasound-guided Regional Anesthesia (UGRA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Senay CanikliUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 27 Nov 2024 (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.
Competence in ultrasound-guided regional anesthesia (UGRA) requires practitioners to acquire cognitive and technical skills. Various difficulties have been identified in anesthesia residents' learning UGRA skills. There is currently no approved UGRA curriculum for residents, and the level of UGRA proficiency achieved during residency may vary significantly. However, no specific training criteria have been defined for this block. It is important to establish criteria to evaluate the adequacy of education.
Detailed description
Compared to other nerve localization techniques, the benefits of UGRA include higher nerve block success rates, faster onset times, reduced local anesthetic volumes, and a lower risk of local anesthetic-related complications. Most experts now consider ultrasound guidance as the standard of care for peripheral nerve blocks. Successfully performing a UGRA procedure requires a triad of three distinct but interrelated skills: image acquisition, anatomical interpretation, and hand-eye coordination.
In our clinic, we routinely perform various nerve block techniques under ultrasound guidance during the perioperative period, both for postoperative analgesia and as a primary anesthetic method. Specifically, in our clinic, the suprainguinal fascia iliaca block (SIFIB) is routinely applied for postoperative analgesia, particularly in orthopedic cases. Before performing a nerve block procedure, resident doctors in our clinic undergo standard training and subsequently perform blocks under the supervision and support of experienced specialists and academicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Anesthesia residents with less than 2 years of anesthesia experience who have never performed a SIFIB before.
Key inclusion criteria (1 listed)
- Anesthesia residents with less than 2 years of anesthesia experience who have never performed a SIFIB before
Key exclusion criteria (1 listed)
- Having previously performed a SIFIB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Block success
Time frame: 20 minute
"Additionally, to evaluate the success of the procedure more objectively, the following parameters will be assessed using a 5-point Likert scale (1: Very low, 2: Low, 3: Moderate, 4: High, 5: Very high). For the procedure to be considered successful, a score of 4 must be obtained for each parameter. These parameters include: * Placement of the ultrasound probe * Visualization of anatomical structures (muscle, bone, fascia, vessels) * Optimization of needle localization * Spread of the drug beneath the iliac fascia"
1 secondary outcome
Block performance time
Time frame: 20 minute
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 22 Jun 2025.
- Background: PubMed 38919433Dang D, Kamal M, Kumar M, Paliwal B, Nayyar A, Bhatia P, Singariya G. Comparison of human cadaver and blue phantom for teaching ultrasound-guided regional anesthesia to novice postgraduate students of anesthesiology: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2024 Apr-Jun;40(2):276-282. doi: 10.4103/joacp.joacp_234_22. Epub 2024 May 16.
- Background: PubMed 30481945Kim TE, Tsui BCH. Simulation-based ultrasound-guided regional anesthesia curriculum for anesthesiology residents. Korean J Anesthesiol. 2019 Feb;72(1):13-23. doi: 10.4097/kja.d.18.00317. Epub 2018 Nov 27.
- Background: PubMed 309462Rossetti M, Allgower D, Hell K. [Azygoportal interruption, fundoplication and vagotomy in hemorrhagic esophageal varices]. Helv Chir Acta. 1977 Oct;44(4):481-4. German.
- Individual participant dataSharing planned: No. Study data can be shared upon appropriate request after the study is completed.
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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.
Senay Canikli Adıgüzel study director
Samsun University
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 Learning Curve and Suprainguinal Fasya Iliaca Block, run by Senay Canikli 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 22 Jun 2025. 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?
Block success (time frame: 20 minute). 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 NCT06708598, which also lists 3 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 22 Jun 2025.