- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07649460
Shoulder Anterior Capsule Block Combined With Supra Scapular Nerve Versus Interscalene Block as Sole Anesthesia in Shoulder Arthroscopy
Shoulder Anterior Capsule Block Combined With Suprascapular Nerve Block Versus Interscalene Block as a Sole Anesthetic Technique for Shoulder Arthroscopy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Ultrasonographic peripheral nerve block has been a popular technique not only for pain management but also for surgical anesthesia especially in patients with comorbidities, avoiding complications associated with general anesthesia (airway-difficulties, hemodynamic instability, etc.) and ensuring excellent pain control, reducing peri-operative consumption of opioids and their side effects, and improving patient satisfaction.
Interscalene block (ISB) is the gold stander anesthetic technique for shoulder surgeries but hemi-diaphragmatic paralysis still problematic. The SHAC is the combination of two different blocks. The first block is the inter fascial space between the deep layer of the deltoid fascia and the superficial layer of the subscapularis fascia, anterior to the subscapularis myotendinous junction. This inter fascial space, we can reach both the axillary nerve and the subscapular nerves, the lateral pectoral nerve, and the musculocutaneous nerve results in achieving adequate anesthesia and analgesia without phrenic nerve affection.
The present study will be conducted to compare of SHAC block combined with suprascapular nerve block and Interscalene block as an anesthetic option in shoulder arthroscopic surgery may allow adequate postoperative analgesia and decrease the overall opioid usage and enhanced patient recovery
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sharqia Province
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Zagazig, Sharqia Province, Egipto
- Zagazig University Hospitals
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Written informed consent from patients.
- BMI less than or equal 30 kgm .
- Age 18-75 years old.
- ASA class I, II and III.
Exclusion Criteria:
- Allergy to local anesthetics.
- Infection at site of injection.
- Patients with coagulopathy.
- Physical and mental disease which could interfere with pain scores evaluation.
- pre-existing neuropathy of the operative limb.
- Pre-existing sever pulmonary diseases (obstructive or restrictive).
- Patients with distorted local anatomy.
Patients with chronic pain syndrom
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Group SHAC block
Group SHAC block: Patients will receive Ultrasound Guided Shoulder Anterior Capsule block and Suprascapular nerve block
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Group SHAC block: Patients will receive Ultrasound Guided Shoulder Anterior Capsule block and Suprascapular nerve block
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Comparador activo: Group IS block
Group IS block: Patients will receive Ultrasound Guided interscalene brachial plexus block.
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Group IS block: Patients will receive Ultrasound Guided interscalene brachial plexus block.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by using Visual Analogue Scale (VAS)
Periodo de tiempo: From start of surgery and for the 1st 24 hours postoperatively.
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Inter-operative VAS immediately after the block and every 5 minutes for 30 minutes and every 2 hours post-operatively for 24 hours while 0 indicates no pain and 10 the severest pain.
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From start of surgery and for the 1st 24 hours postoperatively.
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by duration of analgesia
Periodo de tiempo: 24 hours postoperatively
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by duration of analgesia.
Duration of postoperative analgesia (from the time of patient recovery till the time of rescue analgesia).
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24 hours postoperatively
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by amount of opioid consumption postoperatively.
Periodo de tiempo: 1st 24 hours postoperatively.
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Assessment of SHAC block efficacy for postoperative analgesia in shoulder arthroscopic surgeries by amount of opioid consumption postoperatively.
Total dose of morphine per mg used during the 1st 24 hours postoperatively.
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1st 24 hours postoperatively.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Safety of SHAC block by monitoring of complications eg. local anesthetic toxicity , hemodynamics instability, phrenic nerve affection, pneumothorax.
Periodo de tiempo: From start of surgery and for the 1st 24 hours.
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Monitoring of complications like local anesthetic toxicity ( restlessness, irritability, confusion, convulsions and arrhythmias) hemodynamics instability, phrenic nerve affection ( diaphragmatic paralysis) , pneumothorax ( decrease in oxygen saturation monitoring, tachypnea, diminished air entry on affected side by auscultation).
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From start of surgery and for the 1st 24 hours.
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Patient satisfaction with the anesthesia and analgesia during and after surgery
Periodo de tiempo: From start of surgery and for the 1st 24 hours postoperatively.
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Patient satisfaction was evaluated by using satisfaction score and patients were graded on a 5-point scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied, and assessed at 24 h post-operation
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From start of surgery and for the 1st 24 hours postoperatively.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 387/10 - june-2024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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