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Cerebral Desaturation Burden After Interscalene or Suprascapular-Axillary Block for Shoulder Arthroscopy

10 november 2026 bijgewerkt door: Muhammed E Aydin, Ataturk University

Comparison of the Effects of Preoperative Interscalene Block and Combined Suprascapular and Axillary Nerve Blocks on Cerebral Desaturation Burden in Patients Undergoing Elective Shoulder Arthroscopy in the Beach-Chair Position Under General Anesthesia: A Prospective Randomized Study

Shoulder arthroscopy is often performed with the patient in an upright beach-chair position. Changes in position and anesthesia may affect blood pressure and oxygen delivery to the brain. This study compares two ultrasound-guided nerve block approaches performed before general anesthesia: interscalene block and combined suprascapular and axillary nerve blocks. Participants will be randomly assigned to one of these approaches. Both groups will receive the same general anesthetic and 20 mL of 0.25% bupivacaine for the assigned block approach. Cerebral oxygen saturation will be monitored continuously using sensors placed on the forehead. The main outcome is the total cerebral desaturation burden, measured as the area below 80% of each participant's baseline cerebral oxygen saturation during monitoring. Other outcomes include the occurrence and duration of desaturation, minimum cerebral oxygen saturation, blood pressure and heart rate events, vasopressor use, and immediate recovery and a Mini-Mental State Examination to assess cognitive functions.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Muhammed Enes Aydin, Associate Professor
  • Telefoonnummer: +905543318289
  • E-mail: enesmd@msn.com

Studie Contact Back-up

Studie Locaties

  • Turkije (Türkiye)
      • Erzurum, Turkije (Türkiye), 25000
        • Werving
        • Ataturk University
        • Contact:
          • Muhammed Enes Aydin, principal investigator
          • Telefoonnummer: 05543318289
          • E-mail: enesmd@msn.com
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age 18-65 years
  • ASA physical status I or II
  • Scheduled for elective shoulder arthroscopy under general anesthesia in the beach-chair position
  • Provides written informed consent

Exclusion Criteria:

  • Allergy to local anesthetics
  • Previous cervical spine surgery
  • History of cerebrovascular disease or carotid artery surgery
  • Serious cardiac disease, including advanced heart failure or significant valvular disease
  • Neurological disease, including epilepsy, multiple sclerosis, or Parkinson's disease
  • Dementia or cognitive impairment
  • Coagulopathy or contraindication to peripheral nerve block due to anticoagulant use
  • Pregnancy
  • Body mass index greater than 35 kg/m²
  • Technical or anatomical obstacle to performing the planned nerve block

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Interscalene Block (ISB)

Participants will receive a preoperative ultrasound-guided interscalene nerve block using 20 mL of 0.25% bupivacaine.
Procedure: Ultrasound-Guided Interscalene Nerve Block

A preoperative ultrasound-guided interscalene block will be performed with the patient supine and the head turned to the opposite side. A total of 20 mL of 0.25% bupivacaine will be injected around the brachial plexus roots.
Experimenteel: Combined Suprascapular and Axillary Nerve Blocks (SSAX)

Participants will receive preoperative ultrasound-guided suprascapular and axillary nerve blocks. A total of 20 mL of 0.25% bupivacaine will be divided between the two blocks.
Procedure: ltrasound-Guided Combined Suprascapular and Axillary Nerve Blocks

Preoperative ultrasound-guided suprascapular and axillary nerve blocks will be performed. A total of 20 mL of 0.25% bupivacaine will be divided between the two block sites.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total Cerebral Desaturation Burden (AUC)
Tijdsspanne: From baseline measurement before the nerve block until 10 minutes after return to the supine position.

The area under the curve below the desaturation threshold, defined as 80% of baseline regional cerebral oxygen saturation (rSO₂). AUC will be calculated separately for each hemisphere; the mean of the two hemispheres will be used for the primary comparison. Only desaturation episodes lasting at least 15 seconds will be included. The unit is %·min.
From baseline measurement before the nerve block until 10 minutes after return to the supine position.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence and Number of Cerebral Desaturation Events
Tijdsspanne: From baseline measurement before the nerve block until 10 minutes after return to the supine position.

Proportion of participants with, and number of, cerebral desaturation events, defined as a decrease in rSO₂ of at least 20% from baseline lasting at least 15 seconds.
From baseline measurement before the nerve block until 10 minutes after return to the supine position.
Total Time Below the Cerebral Desaturation Threshold
Tijdsspanne: From baseline measurement before the nerve block until 10 minutes after return to the supine position.

Total time during which rSO₂ remains below 80% of baseline.
From baseline measurement before the nerve block until 10 minutes after return to the supine position.
Minimum Right and Left Cerebral rSO₂
Tijdsspanne: From baseline measurement before the nerve block until 10 minutes after return to the supine position.

Minimum rSO₂ values recorded from the right and left frontal hemispheres; values will be assessed separately.
From baseline measurement before the nerve block until 10 minutes after return to the supine position.
Ipsilateral and Contralateral Cerebral Desaturation Burden
Tijdsspanne: From baseline measurement before the nerve block until 10 minutes after return to the supine position.

AUC below the desaturation threshold in the cerebral hemisphere ipsilateral and contralateral to the operated shoulder.
From baseline measurement before the nerve block until 10 minutes after return to the supine position.
Incidence of Intraoperative Hypotension and Bradycardia
Tijdsspanne: During the intraoperative period.

Proportion of participants with hypotension, defined as a decrease in baseline systolic blood pressure of more than 20% or MAP below 65 mmHg, and bradycardia, defined as heart rate below 50 beats/min.
During the intraoperative period.
Total Intraoperative Ephedrine and Norepinephrine Dose
Tijdsspanne: During the intraoperative period.

Total ephedrine dose in mg and total norepinephrine dose in µg administered intraoperatively.
During the intraoperative period.
Post-Anesthesia Care Unit Length of Stay
Tijdsspanne: Perioperative period (immediate postoperative recovery, from post-anesthesia care unit admission to discharge).

Time elapsed, in minutes, from postoperative admission to the post-anesthesia care unit to discharge to the surgical ward. Patients are discharged when the Modified Aldrete Score reaches 9 or higher.
Perioperative period (immediate postoperative recovery, from post-anesthesia care unit admission to discharge).
Modified Aldrete Score at Post-Anesthesia Care Unit Discharge
Tijdsspanne: Perioperative period (at discharge from the post-anesthesia care unit).

The Modified Aldrete Score is recorded at discharge from the post-anesthesia care unit to the surgical ward. The scale assesses activity, respiration, circulation, consciousness, and oxygen saturation. Each component is scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate better physiological recovery from anesthesia. Patients are discharged when the total score reaches 9 or higher.
Perioperative period (at discharge from the post-anesthesia care unit).
Assessment of cognitive functions at the 24th postoperative hour
Tijdsspanne: At the 24th postoperative hour

A Mini-Mental State Examination was performed at the 24th postoperative hour to assess cognitive functions.
At the 24th postoperative hour

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ataturk University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 november 2026

Primaire voltooiing (Geschat)

29 december 2026

Studie voltooiing (Geschat)

29 december 2026

Studieregistratiedata

Eerst ingediend

3 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

10 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • B.30.2.ATA.0.01.00/144
  • 2026/5 (Andere identificatie: Atatürk University Clinical Research Ethics Committee)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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