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NCT Number: NCT07398352

Comparison Of The Effects Of Regional Anesthesia On Brain And Carotid Artery Oxygenation 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.

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Key information

Conditions

Interscalene Block Cerebral Perfusion Shoulder Surgeries Superficial Cervical Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Sanliurfa, Turkey (Türkiye)

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Other names: interscalene block and superficial cervical plexus block

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 diameter of the common carotid artery will be measured longitudinally in millimeters(mm) with the transverse probe of the ultrasound at specified times.

  2. 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

    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.

Other outcomes

  1. Effect of block type on saturation

    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

    Peripheral oxygen saturation will be measured noninvasively from the finger using pulse oximetry.

  2. Effect of block type on blood pressure

    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

    Blood pressure will be measured noninvasively from the arm

  3. Effect of block type on heart rate

    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

    Heart rate will be measured continuously using electrocardiography

Study contacts

Contact information is provided by the study sponsor or research team.

Ramazan ASLANPARÇASI, MD

CONTACT

[email protected]

+905532980247

Tuğba BINGOL TANRIVERDI, MD

CONTACT

[email protected]

+905418842232

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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