SPENG Block Versus Suprascapular and Axillary Nerve Blocks for Pain After Shoulder Arthroscopy (SPENG-RCT)
12 de agosto de 2026 actualizado por: Murat Kaykaç, Izmir City Hospital
Analgesic Efficacy of the Shoulder Posterior Pericapsular Nerve Group Block Versus Combined Posterior Suprascapular and Axillary Nerve Blocks for Shoulder Arthroscopy: A Randomized, Blinded, Non-Inferiority Trial
This prospective, randomized, patient- and assessor-blinded, single-center non-inferiority trial will compare the analgesic efficacy of the Shoulder Posterior Pericapsular Nerve Group (SPENG) block with combined posterior suprascapular and axillary nerve blocks in adults undergoing elective shoulder arthroscopy under general anesthesia.
Both groups will receive the same total volume and concentration of local anesthetic.
The primary outcome will be the highest resting Numeric Rating Scale pain score recorded during the first 24 postoperative hours.
Secondary outcomes will include block performance time, sensory block success in suprascapular and axillary nerve territories, opioid consumption, time to rescue analgesia, motor function, diaphragmatic function, postoperative recovery quality, patient satisfaction, and block-related complications.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Murat KAYKAC, MD
- Número de teléfono: +905330258450
- Correo electrónico: drmuratkaykac@gmail.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age 18 to 70 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled to undergo elective shoulder arthroscopy under general anesthesia
- Able to understand the Numeric Rating Scale for pain assessment
- Able and willing to provide written informed consent
Exclusion Criteria:
- Known allergy or hypersensitivity to local anesthetics used in the study
- Infection at the planned block injection site
- Coagulopathy or ongoing anticoagulant therapy that cannot be appropriately interrupted for peripheral nerve block
- Pre-existing neurological deficit affecting the operative upper extremity
- Moderate or severe pulmonary disease
- Known diaphragmatic dysfunction
- Chronic opioid use
- Chronic pain syndrome
- Body mass index greater than 35 kg/m²
- Pregnancy or breastfeeding
- Inability to understand or reliably report Numeric Rating Scale pain scores
- Inadequate sonographic window preventing safe performance of the allocated block technique before randomization
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: SPENG Block
Participants assigned to this group will receive an ultrasound-guided Shoulder Posterior Pericapsular Nerve Group (SPENG) block before general anesthesia for shoulder arthroscopy.
A total of 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered as a single injection between the posterior glenoid rim and the deep surface of the infraspinatus muscle.
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An ultrasound-guided single-injection posterior pericapsular block.
With the participant in the lateral decubitus position and the operative shoulder uppermost, a high-frequency linear ultrasound transducer will be placed transversely immediately inferior to the posterior acromion.
After identification of the humeral head, articular cartilage, infraspinatus muscle, and posterior glenoid rim, a block needle will be advanced in-plane in a medial-to-lateral direction.
The needle tip will be positioned between the posterior glenoid rim and the deep surface of the infraspinatus muscle, and 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be injected.
Otros nombres:
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Comparador activo: Posterior Suprascapular and Axillary Nerve Blocks
Participants assigned to this group will receive ultrasound-guided posterior suprascapular and axillary nerve blocks before general anesthesia for shoulder arthroscopy.
A total of 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered, consisting of 10 mL for the posterior suprascapular nerve block and 10 mL for the axillary nerve block.
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wo ultrasound-guided nerve blocks will be performed.
For the posterior suprascapular nerve block, the suprascapular nerve will be identified in the suprascapular notch region beneath the supraspinatus muscle, and 10 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered.
For the axillary nerve block, the posterior humeral circumflex artery will be identified using color Doppler in the quadrilateral space, and 10 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered adjacent to the axillary nerve.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Highest Resting Numeric Rating Scale Pain Score During the First 24 Postoperative Hours
Periodo de tiempo: From arrival in the post-anesthesia care unit through 24 hours after surgery
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Resting postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
For each participant, the highest resting NRS score recorded during the first 24 postoperative hours will be used as the primary outcome.
Scheduled assessments will be performed on arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery.
Resting NRS scores obtained immediately before rescue analgesic administration outside these scheduled assessments will also be included when determining the highest value.
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From arrival in the post-anesthesia care unit through 24 hours after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Participants With Complete Dual-Target Sensory Block Success
Periodo de tiempo: 30 minutes after block completion
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Cold sensation will be assessed over the posterior shoulder (suprascapular nerve territory) and lateral deltoid region (axillary nerve territory) using a 3-point scale: 0 = absent sensation, 1 = reduced sensation, and 2 = normal sensation.
Suprascapular sensory component success will be defined as a reduction of at least one grade from baseline in the posterior shoulder region.
Axillary sensory component success will be defined as a reduction of at least one grade from baseline in the lateral deltoid region.
Complete dual-target sensory block success will require successful sensory blockade in both territories in the same participant.
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30 minutes after block completion
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Cumulative Opioid Consumption During the First 24 Postoperative Hours
Periodo de tiempo: From arrival in the post-anesthesia care unit through 24 hours after surgery
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All rescue opioid analgesics administered during the first 24 postoperative hours will be recorded and converted to intravenous morphine-equivalent dose for comparison between groups.
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From arrival in the post-anesthesia care unit through 24 hours after surgery
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Time to First Rescue Analgesic
Periodo de tiempo: From block completion through 24 hours after surgery
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Time from completion of the study block to the first administration of rescue analgesic medication for postoperative pain.
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From block completion through 24 hours after surgery
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Resting Numeric Rating Scale Pain Scores
Periodo de tiempo: On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
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Resting pain intensity will be assessed using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain).
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On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
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Numeric Rating Scale Pain Scores With Movement
Periodo de tiempo: On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
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Pain intensity during standardized shoulder-related movement will be assessed using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain), when clinically feasible.
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On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
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Anterior Shoulder Numeric Rating Scale Pain Score
Periodo de tiempo: At 8, 12, and 24 hours after surgery
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Pain localized predominantly to the anterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10.
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At 8, 12, and 24 hours after surgery
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Posterior Shoulder Numeric Rating Scale Pain Score
Periodo de tiempo: At 8, 12, and 24 hours after surgery
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Pain localized predominantly to the posterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10.
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At 8, 12, and 24 hours after surgery
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Proportion of Participants With Hemidiaphragmatic Paresis
Periodo de tiempo: 30 minutes after block completion
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Diaphragmatic excursion will be assessed using M-mode ultrasonography.
Hemidiaphragmatic paresis will be defined as diaphragmatic excursion 30 minutes after block completion falling to less than 25% of the participant's baseline excursion.
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30 minutes after block completion
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Change in Diaphragmatic Excursion From Baseline
Periodo de tiempo: Baseline and 30 minutes after block completion
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Diaphragmatic excursion will be measured using M-mode ultrasonography as the difference in diaphragm position between resting expiration and deep inspiration.
Three measurements will be obtained and averaged.
Change from baseline will be evaluated after the block.
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Baseline and 30 minutes after block completion
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Shoulder Abduction Motor Strength
Periodo de tiempo: Baseline, 30 minutes after block completion, and 24 hours after surgery
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Shoulder abduction strength will be evaluated using the Medical Research Council (MRC) scale ranging from 0 to 5, with higher scores indicating greater muscle strength.
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Baseline, 30 minutes after block completion, and 24 hours after surgery
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Proportion of Participants With Rebound Pain
Periodo de tiempo: During the first 24 postoperative hours
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Rebound pain will be defined as an increase from an NRS pain score of 3 or lower at the preceding assessment to an NRS score of 7 or higher at the subsequent assessment.
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During the first 24 postoperative hours
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Quality of Recovery-15 Score
Periodo de tiempo: 24 hours after surgery
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Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15).
The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
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24 hours after surgery
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Patient Satisfaction With Perioperative Analgesia
Periodo de tiempo: 24 hours after surgery
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Overall satisfaction with perioperative analgesia will be rated on an 11-point scale from 0 (completely dissatisfied) to 10 (completely satisfied).
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24 hours after surgery
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Number of Participants With Block-Related Complications
Periodo de tiempo: From block performance through postoperative day 7
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Participants will be assessed for block-related adverse events including hematoma, infection, persistent paresthesia, persistent weakness, and other clinically suspected complications.
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From block performance through postoperative day 7
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Block Performance Time
Periodo de tiempo: Periprocedural
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Time required to perform the allocated regional anesthesia technique, measured in seconds from the first contact of the ultrasound transducer with the skin until removal of the block needle after completion of local anesthetic injection.
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Periprocedural
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Murat KAYKAC, MD, İzmir City Hospital
- Director de estudio: Derya ARSLAN YURTLU, Professor, İzmir City Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de noviembre de 2026
Finalización primaria (Estimado)
31 de mayo de 2027
Finalización del estudio (Estimado)
15 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
9 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de agosto de 2026
Publicado por primera vez (Actual)
13 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SPENG-RCT-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request to the principal investigator.
Data will be shared after publication of the main study results, subject to approval of the proposed use and compliance with applicable ethical and institutional data-protection requirements.
Marco de tiempo para compartir IPD
Beginning after publication of the primary study results and available for 5 years thereafter.
Criterios de acceso compartido de IPD
Requests from qualified researchers with a scientifically sound proposal will be considered by the principal investigator.
Data will be provided in de-identified form for approved research purposes and subject to applicable institutional and ethical requirements.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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