Cerebral Desaturation Burden After Interscalene or Suprascapular-Axillary Block for Shoulder Arthroscopy
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Muhammed Enes Aydin, Associate Professor
- Número de teléfono: +905543318289
- Correo electrónico: enesmd@msn.com
Copia de seguridad de contactos de estudio
- Nombre: Emir Sahan, assistant doctor
- Número de teléfono: +905332773733
- Correo electrónico: Emirsahan94@gmail.com
Ubicaciones de estudio
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Erzurum, Turquía (Türkiye), 25000
- Reclutamiento
- Ataturk University
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Contacto:
- Muhammed Enes Aydin, principal investigator
- Número de teléfono: 05543318289
- Correo electrónico: enesmd@msn.com
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Contacto:
- Emir Sahan, assistant doctor
- Número de teléfono: +90-533-277-37-33
- Correo electrónico: Emirsahan94@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Interscalene Block (ISB)
Participants will receive a preoperative ultrasound-guided interscalene nerve block using 20 mL of 0.25% bupivacaine. |
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. |
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Experimental: 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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total Cerebral Desaturation Burden (AUC)
Periodo de tiempo: From baseline measurement before the nerve block until 10 minutes after return to the supine position.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence and Number of Cerebral Desaturation Events
Periodo de tiempo: From baseline measurement before the nerve block until 10 minutes after return to the supine position.
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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.
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Total Time Below the Cerebral Desaturation Threshold
Periodo de tiempo: From baseline measurement before the nerve block until 10 minutes after return to the supine position.
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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.
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Minimum Right and Left Cerebral rSO₂
Periodo de tiempo: From baseline measurement before the nerve block until 10 minutes after return to the supine position.
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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.
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Ipsilateral and Contralateral Cerebral Desaturation Burden
Periodo de tiempo: From baseline measurement before the nerve block until 10 minutes after return to the supine position.
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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.
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Incidence of Intraoperative Hypotension and Bradycardia
Periodo de tiempo: During the intraoperative period.
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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.
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Total Intraoperative Ephedrine and Norepinephrine Dose
Periodo de tiempo: During the intraoperative period.
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Total ephedrine dose in mg and total norepinephrine dose in µg administered intraoperatively. |
During the intraoperative period.
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Post-Anesthesia Care Unit Length of Stay
Periodo de tiempo: Perioperative period (immediate postoperative recovery, from post-anesthesia care unit admission to discharge).
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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).
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Modified Aldrete Score at Post-Anesthesia Care Unit Discharge
Periodo de tiempo: Perioperative period (at discharge from the post-anesthesia care unit).
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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).
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Assessment of cognitive functions at the 24th postoperative hour
Periodo de tiempo: At the 24th postoperative hour
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A Mini-Mental State Examination was performed at the 24th postoperative hour to assess cognitive functions. |
At the 24th postoperative hour
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Vaughn J, Nisman M. Cerebral oxygen desaturation events assessed by near-infrared spectroscopy during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesth Analg. 2010 Aug;111(2):496-505. doi: 10.1213/ANE.0b013e3181e33bd9. Epub 2010 May 27.
- Thanaboriboon C, Vanichvithya P, Jinaworn P. What Is the Risk of Intraoperative Cerebral Oxygen Desaturation in Patients Undergoing Shoulder Surgery in the Beach Chair Position? Clin Orthop Relat Res. 2021 Dec 1;479(12):2677-2687. doi: 10.1097/CORR.0000000000001864.
- Harsanji Drenjancevic I, Drenjancevic D, Davidovic-Cvetko E, Drenjancevic I, Gulam D, Kvolik S. DOES THE ANESTHESIA TECHNIQUE AFFECT ARTERIAL PRESSURE AND REGIONAL CEREBRAL OXYGEN SATURATION DURING SHOULDER ARTHROSCOPY IN THE BEACH CHAIR POSITION? Acta Clin Croat. 2018 Sep;57(3):473-479. doi: 10.20471/acc.2018.57.03.10.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- B.30.2.ATA.0.01.00/144
- 2026/5 (Otro identificador: Atatürk University Clinical Research Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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