Systolic Blood Pressure (20% or Greater Increase)NCT06394960
Factors Predicting Blood Pressure Change With Interscalene Block
An observational study of Systolic Blood Pressure (20% or Greater Increase), run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to identify potential anthropometric features that predict the relationship between the Interscalene Block procedure and changes in blood pressure Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Systolic Blood Pressure (20% or Greater Increase)
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2024to 20 Jul 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participating study center will be Konya City Hospital and the research population will consist of volunteer patients who will undergo elective shoulder surgery under interscalene block.
Who may be able to join
- ASA I-III, elective shoulder surgery will be performed
Who cannot join
- Presence of advanced renal or hepatic insufficiency, serious respiratory or cardiovascular disease
- History of chronic opioid or benzodiazepine use
- Presence of allergy to the local anesthetic drugs used
- ISB contraindication (such as neurological disorder in the extremity to be operated on, diaphragmatic paralysis in the opposite region of the side where the intervention is planned, infection in the intervention area).
- Presence of high level anxiety
- Patients with a Hospital Anxiety and Depression Scale (HADS) cut-off score of 10 for the anxiety subscale and 7 or higher for the depression subscale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Predicting Blood Pressure Change Associated With Interscalene Block, Prospective and Observational Study
The primary aim of this study is to identify potential anthropometric features that predict the relationship between the Interscalene Block procedure and changes in blood pressure
Read the detailed description
This prospective, randomized study will be carried out after obtaining the necessary ethical approval and informed consent from the patients. 110 adult volunteer patients who will undergo ISB for shoulder surgery anesthesia will be included in this study. Evaluation of the patients before ISB and anthropometric measurements before and after Interscalene Block will be performed by an anesthesiologist who is not involved in the study.
- Keywords
- Interscalene Block, Blood Pressure Change, Anterior Scalene Muscle Thickness, Hypertensive Patient
What is being measured
The primary outcome is the main question the study is designed to answer.
Our primary aim in this study is to determine possible anthropometric features that will predict the relationship between interscalene block procedure and blood pressure change.
Various anthropometric measurements (such as "neck diameter", "neck length" and "anterior scalene muscle thickness") may be effective in the spread of the local anesthetic agent during ISB, and these measurements may play a role as a factor in the blood pressure change associated with ISB.
Measured: 60 minute
Secondary outcomes (1)
The secondary aim of this study is to reveal the relationship between interscalene block and heart rate.
Various anthropometric measurements (such as "neck diameter", "neck length" and "anterior scalene muscle thickness") may be effective in the spread of the local anesthetic agent during ISB, and these measurements may play a role as a factor in the heart rate change associated with ISB.
Measured: 60 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start2 May 2024
- Primary completion10 Jul 2024
- Study completion20 Jul 2024
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 Systolic Blood Pressure (20% or Greater Increase)Studies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Sami TUTAR, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394960
- Sponsor's protocol ID
- 13.11.2023-22850
- Status last verified
- Jul 2024
- First submitted
- 29 Apr 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tutar MS, Polat A, Korkmaz R, Aksoy I, Dogar F, Yildirim A, Satici MH, Yildiz M, Kozanhan B. Prediction of hypertensive responses associated with interscalene block, a prospective cohort study. BMC Anesthesiol. 2025 Feb 19;25(1):82. doi: 10.1186/s12871-025-02947-w.
PubMed 39972410
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Predicting Blood Pressure Change Associated With Interscalene Block, Prospective and Observational Study
- ClinicalTrials.gov ID
- NCT06394960
- Acronym / sponsor ID
- 13.11.2023-22850
- Keywords
- Interscalene Block, Blood Pressure Change, Anterior Scalene Muscle Thickness, Hypertensive Patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 1 May 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.
The primary aim of this study is to identify potential anthropometric features that predict the relationship between the Interscalene Block procedure and changes in blood pressure
Detailed description
This prospective, randomized study will be carried out after obtaining the necessary ethical approval and informed consent from the patients. 110 adult volunteer patients who will undergo ISB for shoulder surgery anesthesia will be included in this study. Evaluation of the patients before ISB and anthropometric measurements before and after Interscalene Block will be performed by an anesthesiologist who is not involved in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participating study center will be Konya City Hospital and the research population will consist of volunteer patients who will undergo elective shoulder surgery under interscalene block.
Key inclusion criteria (1 listed)
- ASA I-III, elective shoulder surgery will be performed
Key exclusion criteria (6 listed)
- Presence of advanced renal or hepatic insufficiency, serious respiratory or cardiovascular disease
- History of chronic opioid or benzodiazepine use
- Presence of allergy to the local anesthetic drugs used
- ISB contraindication (such as neurological disorder in the extremity to be operated on, diaphragmatic paralysis in the opposite region of the side where the intervention is planned, infection in the intervention area).
- Presence of high level anxiety
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
Our primary aim in this study is to determine possible anthropometric features that will predict the relationship between interscalene block procedure and blood pressure change.
Time frame: 60 minute
Various anthropometric measurements (such as "neck diameter", "neck length" and "anterior scalene muscle thickness") may be effective in the spread of the local anesthetic agent during ISB, and these measurements may play a role as a factor in the blood pressure change associated with ISB.
1 secondary outcome
The secondary aim of this study is to reveal the relationship between interscalene block and heart rate.
Time frame: 60 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 23 Jul 2024.
- Derived from this study: PubMed 39972410Tutar MS, Polat A, Korkmaz R, Aksoy I, Dogar F, Yildirim A, Satici MH, Yildiz M, Kozanhan B. Prediction of hypertensive responses associated with interscalene block, a prospective cohort study. BMC Anesthesiol. 2025 Feb 19;25(1):82. doi: 10.1186/s12871-025-02947-w.
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.
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 Systolic Blood Pressure (20% or Greater Increase), run by Konya City 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 6 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 23 Jul 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?
Our primary aim in this study is to determine possible anthropometric features that will predict the relationship between interscalene block procedure and blood pressure change. (time frame: 60 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 NCT06394960, 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 23 Jul 2024.