Comparison Of The Effects Of Regional Anesthesia On Brain And Carotid Artery Oxygenation In Shoulder Surgery

NCT07398352 | Recruiting

• 1 other identifier: ISBSPBBO25
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 shoulder surgery.

Conditions

Interscalene Block; Superficial Cervical Block; Cerebral Perfusion; Shoulder Surgeries

Keywords

brain perfusion; carotid artery diameter; interscalene brachial plexus block; superficial cervical plexus block; shoulder surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  From the end of surgery until the first request for postoperative analgesia and the amount of opioid comsumption, assessed up to 24 hours postoperatively

Other Outcomes (3)

• Effect of block type on saturation

  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

• Effect of block type on blood pressure

  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

• Effect of block type on heart rate

  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

Study Arms (2)

interscalene brachial plexus block

ACTIVE COMPARATOR

The effect of interscalene block on cerebral perfusion and carotid diameter in shoulder surgery

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

Procedure: Interscalene brachial plexus block and superficial cervical plexus block

Interventions

Interscalene brachial plexus block PROCEDURE

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

Interscalene brachial plexus block and superficial cervical plexus block PROCEDURE

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.

Also known as: interscalene block and superficial cervical plexus block

Combination of superficial cervical plexus block and interscalene brachial plexus block.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years patient
• American Society of Anesthesiologists (ASA) I-II patient

You may not qualify if:

• 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
• Pregnancy and breastfeeding
• ASA pyhsical status III-V
• Contraindication to regional anesthesia

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead

Study Sites (1)

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Sanliurfa, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 41457137 BACKGROUND

• Cosarcan 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.

  PMID: 34476141 BACKGROUND

• Kaye 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.

  PMID: 39739068 BACKGROUND

Study Officials

• Ramazan ASLANPARÇASI, MD

  Sanliurfa Mehmet Akif Inan Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramazan ASLANPARÇASI, MD

CONTACT

+905532980247; rmzn.aslan.2015@gmail.com

Tuğba BINGOL TANRIVERDI, MD

CONTACT

+905418842232; tuggbabingol@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Of Anesthesiology And Reanimation

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: February 9, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)