SPENG Block Versus Suprascapular and Axillary Nerve Blocks for Pain After Shoulder Arthroscopy (SPENG-RCT)
12 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Murat KAYKAC, MD
- Número de telefone: +905330258450
- E-mail: drmuratkaykac@gmail.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
Outros nomes:
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Highest Resting Numeric Rating Scale Pain Score During the First 24 Postoperative Hours
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of Participants With Complete Dual-Target Sensory Block Success
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Murat KAYKAC, MD, İzmir City Hospital
- Diretor de estudo: Derya ARSLAN YURTLU, Professor, İzmir City Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de novembro de 2026
Conclusão Primária (Estimado)
31 de maio de 2027
Conclusão do estudo (Estimado)
15 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
9 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de agosto de 2026
Primeira postagem (Real)
13 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SPENG-RCT-2026-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Beginning after publication of the primary study results and available for 5 years thereafter.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
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