- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07739303
Anterior Suprascapular and Axillary vs. Interscalene Block for Analgesia and Diaphragmatic Function in Shoulder Surgery
Comparison of Anterior Suprascapular and Axillary Nerve Block Versus Interscalene Block for Postoperative Analgesia and Diaphragmatic Function in Shoulder Surgery: A Randomized Controlled Trial
Shoulder surgeries are among the most frequently performed orthopedic interventions and are often associated with moderate to severe postoperative pain. In these procedures, effective pain management is crucial for early rehabilitation and patient comfort.
Peripheral nerve blockade is widely used for postoperative analgesia in shoulder surgery. While the interscalene brachial plexus block is considered the gold standard for pain control, it is frequently associated with unintended phrenic nerve blockade, leading to hemidiaphragmatic paresis. To minimize respiratory complications while maintaining effective analgesia, alternative diaphragm-sparing regional anesthesia techniques, such as the combination of suprascapular and axillary nerve blocks, have been introduced.
The aim of this study is to compare the analgesic efficacy and respiratory functions preservation of the ultrasound-guided anterior approach suprascapular combined with axillary nerve block versus interscalene block in patients undergoing shoulder surgery
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: İbrahim Topcu
- Número de telefone: +905437860316
- E-mail: ibrahimtpc78@gmail.com
Estude backup de contato
- Nome: Musa Zengin
- Número de telefone: +905307716235
- E-mail: musazengin@gmail.com
Locais de estudo
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Ankara
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Yenimahalle, Ankara, Turquia (Türkiye), 06170
- Recrutamento
- Ankara Etlik City Hospital
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Contato:
- İbrahim Topcu
- Número de telefone: +905437860316
- E-mail: ibrahimtpc78@gmail.com
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Contato:
- Musa Zengin
- Número de telefone: +905307716235
- E-mail: musazengin@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Patients aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Patients scheduled to undergo elective arthroscopic shoulder surgery
- BMI between 18 and 30 kg/m2
- Ability to provide written informed consent
Exclusion Criteria:
- Known allergy or hypersensitivity to local anesthetics
- Presence of localized infection at the planned injection site
- Severe coagulopathy or active use of anticoagulant medications
- Contralateral phrenic nerve palsy or a diagnosis of severe chronic obstructive pulmonary disease (COPD)
- History of chronic opioid consumption or neuropathic pain
Plano de estudo
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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Comparador Ativo: Interscalene Block
After the patients are placed under monitoring and positioned supine, and appropriate field sterilization is achieved, the ultrasound probe will be positioned transversely at the level of the cricoid cartilage (C6) with the head turned to the contralateral side.
Advancing the needle laterally into the interscalene groove between the anterior and middle scalene muscles, 10 mL of local anesthetic (%0.5 bupivacaine ) will be injected between the C5 and C6 nerve roots.
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Interscalene block will be performed on the patients using 10 mL of 0.5% bupivacaine under ultrasound guidance.
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Comparador Ativo: Combination of Axillary and Anterior Suprascapular Blocks
After the patients are placed under monitoring and positioned supine, and appropriate field sterilization is achieved, the ultrasound probe will be positioned transversely in the supraclavicular fossa with the head turned to the contralateral side.
Advancing the needle in-plane, 5 mL of local anesthetic (%0.5 bupivacaine) will be injected around the suprascapular nerve as it branches anteriorly from the superior trunk of the brachial plexus.
Subsequently, for the axillary nerve block, the patient will be positioned laterally and the ultrasound probe will be placed longitudinally over the posterior aspect of the shoulder.
Advancing the needle into the quadrangular space, 5 mL of local anesthetic (%0.5 bupivacaine) will be injected around the axillary nerve adjacent to the posterior circumflex humeral artery.
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Combined anterior suprascapular(5 ml) and axillary nerve blocks(5 ml) will be performed on the patients using a total of 10 mL of 0.5% bupivacaine under ultrasound guidance.
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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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Postoperative Pain Intensity at Rest
Prazo: 4 hours after surgery.
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Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest.
Pain assessment at rest will be made at 4 hours after surgery.
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4 hours after surgery.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Postoperative Pain Intensity at Rest
Prazo: Up to 24 hours
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Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest.
Pain assessment at rest will be made at 1, 8, 12, and 24 hours after surgery.
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Up to 24 hours
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Postoperative Pain Intensity at Movement
Prazo: Up to 24 hours
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Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at movement.
Pain assessment at rest will be made at 1, 4, 8, 12, and 24 hours after surgery.
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Up to 24 hours
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Total Postoperative Opioid Consumption
Prazo: Up to 24 hours
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The total amount of opioid consumed by the patient will be recorded.
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Up to 24 hours
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Area Under Curve
Prazo: At the 24th hour
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Cumulative 24-hour pain burden calculated by the trapezoidal rule
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At the 24th hour
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Diaphragmatic Excursion
Prazo: Baseline (immediately before block performance) and 30 minutes after block performance
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Diaphragmatic excursion will be measured in centimeters (cm) using M-mode ultrasonography during normal breathing and deep breathing (sniff test).
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Baseline (immediately before block performance) and 30 minutes after block performance
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Forced vital capacity (FVC) (volume)
Prazo: Perioperative period
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Forced vital capacity (FVC) (volume) will be evaluated during the perioperative period.
Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1 and 24 hours.
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Perioperative period
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Forced expiratory flow in 1 s (FEV1) (volume)
Prazo: Perioperative period
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Forced expiratory flow in 1 s (FEV1) (volume) will be evaluated during the perioperative period.
Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1 and 24 hours.
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Perioperative period
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FEV1/FVC
Prazo: Perioperative period
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FEV1/FVC will be evaluated during the perioperative period.
Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1 and 24 hours.
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Perioperative period
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
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Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
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Última atualização enviada que atendeu aos critérios de controle de qualidade
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- AEŞH-EK-2026-142
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