Interscalene BlockNCT07398352
Comparison Of The Effects Of Regional Anesthesia On Brain And Carotid Artery Oxygenation In Shoulder Surgery
A study testing Interscalene brachial plexus block and Interscalene brachial plexus block and superficial cervical plexus block in people with Interscalene Block and Superficial Cervical Block, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to compare the effects of interscalene block alone and the combination of interscalene block and superficial cervical block on cerebral oxygenation, carotid artery diameter, intraoperative hemodynamics, laboratory parameters, clinical course and postoperative pain in patients undergoing… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interscalene Block, Superficial Cervical Block, Cerebral Perfusion
- What is being tested?
- Interscalene brachial plexus block and Interscalene brachial plexus block and superficial cervical plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2026to 15 Dec 2026
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years patient
- American Society of Anesthesiologists (ASA) I-II patient
Who cannot join
- Age < 18 years or > 65 years
- History of carotid endarterectomy
- History of cerebrovascular accident(CVA)
- Body Mass index (BMI)>35 kg/m²
- Inability to cooperate or comply with study procedures
- Liver and kidney failure
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- Pregnancy and breastfeeding
- ASA pyhsical status III-V
- Contraindication to regional anesthesia
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, 1 recruiting
- Recruiting
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sanliurfa
About this study
Official title: Comparison Of The Effect Of Interscalene Block Alone And The Combination Of Interscalene Block And Superficial Cervical Block On Brain Oxygenation And Carotid Artery Diameter In Shoulder Surgery
The aim of our study was to compare the effects of interscalene block alone and the combination of interscalene block and superficial cervical block on cerebral oxygenation, carotid artery diameter, intraoperative hemodynamics, laboratory parameters, clinical course and postoperative pain in patients undergoing shoulder surgery.
Read the detailed description
This study aimed to compare the effects of interscalene block alone and interscalene block combined with superficial cervical plexus block on cerebral oxygenation, carotid artery diameter, intraoperative hemodynamics, and postoperative pain in patients undergoing shoulder surgery.
Peripheral nerve blocks, particularly interscalene block, are commonly used in shoulder surgery due to their superior analgesic efficacy. Cerebral oxygenation was assessed using near-infrared spectroscopy (NIRS), a non-invasive method that reflects regional tissue oxygenation. The effects of both block techniques on bilateral cerebral oxygenation and carotid artery diameter were evaluated using NIRS and ultrasonography, respectively
- Being tested
- Interscalene brachial plexus block, Interscalene brachial plexus block and superficial cervical plexus block
- Keywords
- brain perfusion, carotid artery diameter, interscalene brachial plexus block, superficial cervical plexus block, shoulder surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockProcedure or surgery
After sedating the patient with 2 mg midazolam, baseline values will be obtained, and an interscalene block will be performed under ultrasound guidance.
Before the block, rSO2 values of both hemispheres of the brain and carotid artery diameter (at T1 and T5 times) will be measured and recorded using a NIRS probe at T2: 5 minute(min), T3: 10 min, T4: 15 min, and T5: 20 min.
To assess the quality of the block, the sensory block will be evaluated at 20 minutes. The patient will be placed in a supine position, and after the first rSO2 value is obtained at T6, rSO2 values will be recorded at T7: 10 min, T8: 30 min, T9: 60 min, T10: surgical completion, and T11: 5 min postoperatively in the supine position. Bilateral carotid diameter(mm) will be measured at T6, T10, and T11. Before any postoperative analgesia is administered, the time of the patient's first pain and their need for analgesic will be recorded.
Interscalene brachial plexus block and superficial cervical plexus blockProcedure or surgery
Also called interscalene block and superficial cervical plexus block
After sedating the patient with 2 mg midazolam, baseline values will be obtained, and a combined interscalene and superficial cervical block will be performed under ultrasound guidance.
Before the block, rSO2 values of both hemispheres of the brain and carotid artery diameter(mm) (at T1 and T5 times) will be measured and recorded using a NIRS probe at T2: 5 minute, T3: 10 minute, T4: 15 minute, and T5: 20 minute.
To assess the quality of the block, the sensory block will be evaluated at 20 minutes. The patient will be placed in a supine position, and after the first rSO2 value is obtained at T6, rSO2 values will be recorded at T7: 10 minute, T8: 30 minute, T9: 60 minute, T10: surgical completion, and T11: 5 minute postoperatively in the supine position. Bilateral carotid diameter(mm) will be measured at T6, T10, and T11. Before any postoperative analgesia is administered, the time of the patient's first pain, and their need for analgesic will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| interscalene brachial plexus block | Active comparator | The effect of interscalene block on cerebral perfusion and carotid diameter in shoulder surgery Receives: Procedure: Interscalene brachial plexus block |
| Combination of superficial cervical plexus block and interscalene brachial plexus block. | Experimental | Effects of combined interscalene block and superficial cervical block on cerebral perfusion and carotid diameter in shoulder surgery Receives: Procedure: Interscalene brachial plexus block and superficial cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of regional anesthesia on cerebral oxygenation
We plan to investigate the effect of interscalene block or a combination of interscalene and superficial cervical block on oxygenation of both hemispheres of the brain using a NIRS probe.
Measured: Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute
Secondary outcomes (2)
The effect of regional anesthesia on carotid artery diameter
The diameter of the common carotid artery will be measured longitudinally in millimeters(mm) with the transverse probe of the ultrasound at specified times.
Measured: Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute
The effect of the two-block method on the duration of first postoperative analgesia requirement and opioid consumption
The patient will not receive routine analgesia postoperatively. The time(hour) of the first request for analgesia and the amount of opioid consumption within the first 24 postoperative hours will be evaluated.
Measured: From the end of surgery until the first request for postoperative analgesia and the amount of opioid comsumption, assessed up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start23 Feb 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
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 Interscalene BlockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMAZAN ASLANPARÇASI, Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Investigators
- Ramazan ASLANPARÇASI, MD, Principal investigator, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398352
- Sponsor's protocol ID
- ISBSPBBO25
- Status last verified
- Mar 2026
- First submitted
- 24 Dec 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethics committee approval covers only aggregate data analysis; there is no permission to share individual participant data.
Publications
Ahmadzadeh S, Naccari BP, Amedio LS, Koruna AE, Bass D, Shekoohi S, Kaye AD. Efficacy of Suprascapular Versus Interscalene Block for Post-Operative Pain Management in Shoulder Surgeries: A Narrative Review. Curr Pain Headache Rep. 2025 Dec 29;30(1):13. doi: 10.1007/s11916-025-01443-7.
PubMed 41457137Cosarcan SK, Gurkan Y, Dogan AT, Koyuncu O, Ercelen O. Could Interscalene Block Possibly be Protective Against Cerebral Ischemia During Shoulder Surgery in a Beach Chair Position? Cureus. 2021 Jul 31;13(7):e16773. doi: 10.7759/cureus.16773. eCollection 2021 Jul.
PubMed 34476141Kaye AD, Upshaw WC, Holley C, Bailey PD, Tassin JP, Frolov MV, Sudini S, Miller BC, Palowsky ZR, Kataria S, Ahmadzadeh S, Shekoohi S, Robinson CL. Overview and Comparison of Interscalene Block Techniques for Brachial Plexus Pain Management. Curr Pain Headache Rep. 2024 Dec 30;29(1):1. doi: 10.1007/s11916-024-01346-z.
PubMed 39739068
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effect Of Interscalene Block Alone And The Combination Of Interscalene Block And Superficial Cervical Block On Brain Oxygenation And Carotid Artery Diameter In Shoulder Surgery
- ClinicalTrials.gov ID
- NCT07398352
- Acronym / sponsor ID
- ISBSPBBO25
- Keywords
- brain perfusion, carotid artery diameter, interscalene brachial plexus block, superficial cervical plexus block, shoulder surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Feb 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 aim of our study was to compare the effects of interscalene block alone and the combination of interscalene block and superficial cervical block on cerebral oxygenation, carotid artery diameter, intraoperative hemodynamics, laboratory parameters, clinical course and postoperative pain in patients undergoing shoulder surgery.
Detailed description
This study aimed to compare the effects of interscalene block alone and interscalene block combined with superficial cervical plexus block on cerebral oxygenation, carotid artery diameter, intraoperative hemodynamics, and postoperative pain in patients undergoing shoulder surgery.
Peripheral nerve blocks, particularly interscalene block, are commonly used in shoulder surgery due to their superior analgesic efficacy. Cerebral oxygenation was assessed using near-infrared spectroscopy (NIRS), a non-invasive method that reflects regional tissue oxygenation. The effects of both block techniques on bilateral cerebral oxygenation and carotid artery diameter were evaluated using NIRS and ultrasonography, respectively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interscalene brachial plexus block | Active comparator | Procedure: Interscalene brachial plexus blockThe effect of interscalene block on cerebral perfusion and carotid diameter in shoulder surgery |
| Combination of superficial cervical plexus block and interscalene brachial plexus block. | Experimental | Procedure: Interscalene brachial plexus block and superficial cervical plexus blockEffects of combined interscalene block and superficial cervical block on cerebral perfusion and carotid diameter in shoulder surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years patient
- American Society of Anesthesiologists (ASA) I-II patient
Key exclusion criteria (9 listed)
- Age < 18 years or > 65 years
- History of carotid endarterectomy
- History of cerebrovascular accident(CVA)
- Body Mass index (BMI)>35 kg/m²
- Inability to cooperate or comply with study procedures
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 |
|---|---|---|
| Interscalene brachial plexus blockAfter sedating the patient with 2 mg midazolam, baseline values will be obtained, and an interscalene block will be performed under ultrasound guidance. Before the block, rSO2 values of both hemispheres of the brain and carotid artery diameter (at T1 and T5 times) will be measured and recorded using a NIRS probe at T2: 5 minute(min), T3: 10 min, T4: 15 min, and T5: 20 min. To assess the quality of the block, the sensory block will be evaluated at 20 minutes. The patient will be placed in a supine position, and after the first rSO2 value is obtained at T6, rSO2 values will be recorded at T7: 10 min, T8: 30 min, T9: 60 min, T10: surgical completion, and T11: 5 min postoperatively in the supine position. Bilateral carotid diameter(mm) will be measured at T6, T10, and T11. Before any postoperative analgesia is administered, the time of the patient's first pain and their need for analgesic will be recorded. | Procedure or surgery | interscalene brachial plexus block |
| Interscalene brachial plexus block and superficial cervical plexus blockAlso: interscalene block and superficial cervical plexus blockAfter sedating the patient with 2 mg midazolam, baseline values will be obtained, and a combined interscalene and superficial cervical block will be performed under ultrasound guidance. Before the block, rSO2 values of both hemispheres of the brain and carotid artery diameter(mm) (at T1 and T5 times) will be measured and recorded using a NIRS probe at T2: 5 minute, T3: 10 minute, T4: 15 minute, and T5: 20 minute. To assess the quality of the block, the sensory block will be evaluated at 20 minutes. The patient will be placed in a supine position, and after the first rSO2 value is obtained at T6, rSO2 values will be recorded at T7: 10 minute, T8: 30 minute, T9: 60 minute, T10: surgical completion, and T11: 5 minute postoperatively in the supine position. Bilateral carotid diameter(mm) will be measured at T6, T10, and T11. Before any postoperative analgesia is administered, the time of the patient's first pain, and their need for analgesic will be recorded. | Procedure or surgery | Combination of superficial cervical plexus block and interscalene brachial plexus block. |
Primary outcome
The effect of regional anesthesia on cerebral oxygenation
Time frame: Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute
We plan to investigate the effect of interscalene block or a combination of interscalene and superficial cervical block on oxygenation of both hemispheres of the brain using a NIRS probe.
2 secondary outcomes
The effect of regional anesthesia on carotid artery diameter
Time frame: Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute
The effect of the two-block method on the duration of first postoperative analgesia requirement and opioid consumption
Time frame: From the end of surgery until the first request for postoperative analgesia and the amount of opioid comsumption, assessed up to 24 hours postoperatively
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 24 Mar 2026.
- Background: PubMed 41457137Ahmadzadeh S, Naccari BP, Amedio LS, Koruna AE, Bass D, Shekoohi S, Kaye AD. Efficacy of Suprascapular Versus Interscalene Block for Post-Operative Pain Management in Shoulder Surgeries: A Narrative Review. Curr Pain Headache Rep. 2025 Dec 29;30(1):13. doi: 10.1007/s11916-025-01443-7.
- Background: PubMed 34476141Cosarcan SK, Gurkan Y, Dogan AT, Koyuncu O, Ercelen O. Could Interscalene Block Possibly be Protective Against Cerebral Ischemia During Shoulder Surgery in a Beach Chair Position? Cureus. 2021 Jul 31;13(7):e16773. doi: 10.7759/cureus.16773. eCollection 2021 Jul.
- Background: PubMed 39739068Kaye AD, Upshaw WC, Holley C, Bailey PD, Tassin JP, Frolov MV, Sudini S, Miller BC, Palowsky ZR, Kataria S, Ahmadzadeh S, Shekoohi S, Robinson CL. Overview and Comparison of Interscalene Block Techniques for Brachial Plexus Pain Management. Curr Pain Headache Rep. 2024 Dec 30;29(1):1. doi: 10.1007/s11916-024-01346-z.
- Individual participant dataSharing planned: No. Ethics committee approval covers only aggregate data analysis; there is no permission to share individual participant data.
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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.
Ramazan ASLANPARÇASI, MD principal investigator
Sanliurfa Mehmet Akif Inan Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene brachial plexus block and Interscalene brachial plexus block and superficial cervical plexus block in people with Interscalene Block and Superficial Cervical Block, run by Sanliurfa Mehmet Akif Inan Education 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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 24 Mar 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?
Contact Ramazan ASLANPARÇASI, MD (+905532980247, rmzn.aslan.2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of regional anesthesia on cerebral oxygenation (time frame: Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. 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 NCT07398352, 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 24 Mar 2026.