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Interscalene BlocksNCT07688889

The Effect of Anthropometric Measurements on Block Success, Performance Time , and Ultrasound Visibility Score.

An observational study of Interscalene Blocks, run by Amasya University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The primary objective of this study is to determine whether patients' physical characteristics hold predictive value regarding the difficulty or ease of performing an interscalene block. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Interscalene Blocks
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
16 Jun 2026to 1 Mar 2027
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients who will undergo interscalene block

Who may be able to join

  • Patients over 18 years of age who will undergo shoulder arthroscopy and intrascalne block.

Who cannot join

  • Under 18 years old
  • allergy to local anesthetics
  • bleeding diathesis
  • Lack of patient consent
  • patient's unwillingness

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Amasya University Training and Research Hospital

    Amasya, 05100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Anthropometric Measurements of Patients Undergoing Interscalene Block on Block Success, Performance Time , and Ultrasound Visibility Score.

The primary objective of this study is to determine whether patients' physical characteristics hold predictive value regarding the difficulty or ease of performing an interscalene block. By pre-identifying patients prone to difficult blocks, predicting procedure duration, and elucidating the factors influencing ultrasound image quality, this study aims to contribute to clinical practice and patient safety.

Read the detailed description

Anthropometric measurements will be performed using a standard tape measure while the patient is in the supine position with the neck in a neutral and fully extended position. Neck circumference measured at the level of the cricoid cartilage, sternomental distance (the distance between the manubrium sterni and the mentum), and thyromental distance (the distance between the thyroid cartilage and the mentum) will be measured and recorded. Additionally, the ratio of neck circumference to thyromental distance will be calculated and added to the data.

Block Performance and Technical Data Observational data will be collected while the interscalene nerve block, which is routinely performed for upper extremity surgeries at our center, is administered under standard conditions. The moment the ultrasound probe touches the skin will be defined as the "block onset time," and the moment the block needle is withdrawn from the skin will be defined as the "block completion time." The difference between these two time points will be recorded as the "total performance time." If the number of needle insertions into the skin (number of punctures) is more than one, it will be specified. Under ultrasound guidance, brachial plexus depth (the distance between the skin and the C5 spinal nerve root, in cm) will be measured. The active ingredient and volume (mL) of the administered local anesthetic drug will be recorded in the data form.

Image Quality and Clinical Evaluation Ultrasound screen images obtained during the procedure will later be shown to 5 anesthesiology and reanimation specialists specified in the study plan, and they will be scored between 1 and 5 in terms of the clarity of anatomical structures.

At 5, 10, and 20 minutes following the block performance:

Sensory Block: evaluated in the C5 and C6 dermatome areas, Motor Block: evaluated via elbow flexion, Vital Signs: SpO_2 measured by peripheral pulse oximetry and heart rate (beats/minute) values will be monitored and recorded.

Success Criteria and Follow-up At the end of the 20th minute, block success will be evaluated by assessing whether the level of anesthesia required for surgery has been achieved. In cases where the block is insufficient, fails, or conversion to general anesthesia is required for any other reason, the reasons will be noted in detail.

Potential side effects and complications that may develop after the procedure (e.g., Horner's syndrome, hoarseness, dyspnea, vascular puncture, local anesthetic systemic toxicity [LAST]) will be monitored up to the 6th postoperative hour. In addition, the study will be completed by recording the total narcotic analgesic consumption in the first 24 hours, the patient satisfaction score at the 6th postoperative hour (scored from 0 to 10), and the Visual Analog Scale (VAS) score (scored from 0 to 10).

The obtained data will be analyzed using the SPSS software with appropriate statistical methods (correlation analysis, regression, etc.) to determine the relationship between anthropometric measurements, duration, and success.

Keywords
intercalene block, body mass index, andropometric

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07688889
Study groupRoleWhat they receive
BMI<30patients with a body mass index below 30
BMI>30patients with a body mass index above 30

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. USG block application success

    Evaluation of the success of ultrasound block application.

    Measured: 1 day

  2. block visibility score

    USG evaluation of block visibility

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start16 Jun 2026
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

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
84 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07688889
Sponsor's protocol ID
bca05
Status last verified
Jun 2026
First submitted
30 Jun 2026
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: patient block application time, block success, and ultrasound visibility score

Publications

  • Birnbaum J, Diederich L, Ertmer M, Balzer F, Hofmann F, Klotz E, Trauzeddel RF, Volk T, Wernecke KD, Wismayer A, Birnbaum M, Hensel M. A new score for characterizing the visibility of anatomical structures during ultrasound guided regional anesthesia: a retrospective cohort study. Minerva Anestesiol. 2020 Sep;86(9):922-929. doi: 10.23736/S0375-9393.20.14213-5. Epub 2020 Jul 8.

    PubMed 32643357

Questions about this trial

What is this clinical trial studying?

An observational study of Interscalene Blocks, run by Amasya University 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 5 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: enrolling by invitation, as of the sponsor's last update on 7 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

USG block application success (time frame: 1 day). The study lists 2 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 NCT07688889, which also lists 1 linked publication.

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 7 Jul 2026.

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