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).
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
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.
- Conditions
- Interscalene Blocks
- 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 group | Role | What they receive |
|---|---|---|
| BMI<30 | patients with a body mass index below 30 | |
| BMI>30 | patients with a body mass index above 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
USG block application success
Evaluation of the success of ultrasound block application.
Measured: 1 day
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.
- First posted7 Jul 2026
- Study start16 Jun 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interscalene BlocksStudies 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
- 84 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anthropometric Measurements of Patients Undergoing Interscalene Block on Block Success, Performance Time , and Ultrasound Visibility Score.
- ClinicalTrials.gov ID
- NCT07688889
- Acronym / sponsor ID
- bca05
- Conditions
- Interscalene Blocks
- Keywords
- intercalene block, body mass index, andropometric
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 7 Jul 2026 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI<30 | – | –patients with a body mass index below 30 |
| BMI>30 | – | –patients with a body mass index above 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who will undergo interscalene block
Key inclusion criteria (1 listed)
- Patients over 18 years of age who will undergo shoulder arthroscopy and intrascalne block.
Key exclusion criteria (5 listed)
- Under 18 years old
- allergy to local anesthetics
- bleeding diathesis
- Lack of patient consent
- patient's unwillingness
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
USG block application success
Time frame: 1 day
Evaluation of the success of ultrasound block application.
block visibility score
Time frame: 1 day
USG evaluation of block visibility
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 32643357Birnbaum 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.
- Individual participant dataSharing planned: Yes. patient block application time, block success, and ultrasound visibility score
Related trials for Interscalene Blocks
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
RecruitingPhase 4
Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement
Total Shoulder Arthroplasty
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
Not yet recruiting
Combined Suprascapular and PECS I Blocks Versus Interscalene Block for Shoulder Arthroscopy
Postoperative Pain, Hemidiaphragmatic Paresis
RecruitingPhase 4
Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
Pain, Postoperative, Rebound Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.