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

March 23, 2026 updated by: RAMAZAN ASLANPARÇASI, Sanliurfa Mehmet Akif Inan Education and Research Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Sanliurfa, Turkey (Türkiye)
        • Recruiting
        • Sanliurfa Mehmet Akif Inan Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: interscalene brachial plexus block
The effect of interscalene block on cerebral perfusion and carotid diameter in shoulder surgery
Procedure: Interscalene 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.
Experimental: Combination of superficial cervical plexus block and interscalene brachial plexus block.
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Investigators

  • Principal Investigator: Ramazan ASLANPARÇASI, MD, Sanliurfa Mehmet Akif Inan Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ISBSPBBO25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethics committee approval covers only aggregate data analysis; there is no permission to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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