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

10. november 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Muhammed Enes Aydin, Associate Professor
  • Telefonnummer: +905543318289
  • E-post: enesmd@msn.com

Studer Kontakt Backup

Studiesteder

  • Tyrkia (Türkiye)
      • Erzurum, Tyrkia (Türkiye), 25000
        • Rekruttering
        • Ataturk University
        • Ta kontakt med:
          • Muhammed Enes Aydin, principal investigator
          • Telefonnummer: 05543318289
          • E-post: enesmd@msn.com
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Interscalene Block (ISB)

Participants will receive a preoperative ultrasound-guided interscalene nerve block using 20 mL of 0.25% bupivacaine.
Fremgangsmåte: 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.
Eksperimentell: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total Cerebral Desaturation Burden (AUC)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence and Number of Cerebral Desaturation Events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ataturk University

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. november 2026

Primær fullføring (Antatt)

29. desember 2026

Studiet fullført (Antatt)

29. desember 2026

Datoer for studieregistrering

Først innsendt

3. november 2026

Først innsendt som oppfylte QC-kriteriene

10. november 2026

Først lagt ut (Faktiske)

12. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

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

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Nei

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