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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07398352
Enrollment
70
Registered
2026-02-09
Start date
2026-02-23
Completion date
2026-12-15
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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

Interventions

PROCEDUREInterscalene brachial plexus block

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.

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.

Sponsors

Sanliurfa Mehmet Akif Inan Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 18-65 years patient * American Society of Anesthesiologists (ASA) I-II patient

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The effect of regional anesthesia on cerebral oxygenationBefore 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. minuteWe 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.

Secondary

MeasureTime frameDescription
The effect of regional anesthesia on carotid artery diameterBefore 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. minuteThe diameter of the common carotid artery will be measured longitudinally in millimeters(mm) with the transverse probe of the ultrasound at specified times.
The effect of the two-block method on the duration of first postoperative analgesia requirement and opioid consumptionFrom the end of surgery until the first request for postoperative analgesia and the amount of opioid comsumption, assessed up to 24 hours postoperativelyThe 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTRamazan ASLANPARÇASI, MD
rmzn.aslan.2015@gmail.com+905532980247
CONTACTTuğba BINGOL TANRIVERDI, MD
tuggbabingol@gmail.com+905418842232
PRINCIPAL_INVESTIGATORRamazan ASLANPARÇASI, MD

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026