Bloqueo del Plano Muscular Transverso Torácico versus Bloqueo Fascial Pectointercostal para la Recuperación Mejorada tras Cirugía Cardíaca
Bloqueo del Plano Muscular Transverso Torácico versus Bloqueo Fascial Pectointercostal para la Recuperación Mejorada Después de la Cirugía Cardíaca: Un Ensayo Controlado Aleatorio
This work aims to assess the analgesic efficacies of transversus thoracic muscle plane block (TTPB) and transversus thoracic muscle plane block (TTPB) for open cardiac surgeries
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In patients undergoing open cardiac operation, pain management is crucial to the improved recovery. Postcardiac surgery pain is significant due to the sternotomy. The sternotomy is commonly cited as the most painful location following cardiac surgery, and postoperative pain is at its worst within the first 24 hours.
The transversus thoracic muscle plane block (TTPB) and the pectointercostal fascial block (PIFB) are new ultrasound (US)-guided regional anesthesia techniques planned to provide analgesia to the anterior thoracic wall. Both blocks primarily target the anterior cutaneous branches of the intercostal nerves (T2-T6), which are responsible for innervating the parasternal and medial anterior chest wall regions.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Asyut Governorate
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Asyut, Asyut Governorate, Egipto, 71515
- Assiut University
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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 from 40 to 60 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status II-III.
- Body mass index (BMI) < 35 kg/m2.
- Underwent cardiac surgery (coronary artery bypass graft surgery with median sternotomy).
Exclusion Criteria:
- Valve replacement procedures.
- Emergency operations.
- Redo surgeries.
- Minimally invasive approaches.
- The presence of psychiatric disorders.
- Cognitive impairment preventing accurate assessment using the verbal numerical rating scale (NRS).
- Known hypersensitivity or a history of allergy to local anesthetics.
- Had severe major organ dysfunction.
- Left ventricular ejection fraction below 30%.
- Pregnancy or breastfeeding.
Plan de estudios
¿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: Group PIFB
Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
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Experimental: Group TTPB
Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg). |
|
Comparador falso: Control Group
Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially. |
Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total amount analgesic requirement
Periodo de tiempo: 24 hours postoperatively
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In cases where rescue analgesia is required [numerical rating scale (NRS) ≥4], intravenous Nalbuphine 0.1 mg/kg will be given. |
24 hours postoperatively
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Degree of pain
Periodo de tiempo: 24 hours postoperatively
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Degree of pain will be assessed using Numerical rating scale (NRS) from 0 (no pain) to 10 (worst severe pain). NRS will be measured at 2h, 4h, 8h, 16h and 24h after surgery. |
24 hours postoperatively
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The number of patients required rescue analgesia
Periodo de tiempo: 24 hours postoperatively
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The number of patients requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation. |
24 hours postoperatively
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Postoperative nausea and vomiting (PONV)
Periodo de tiempo: 24 hours postoperatively
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The patients will be verbally evaluated according to a descriptive five-point postoperative nausea and vomiting (PONV) scale at 0, 3, 6, 12, 18, and 24 hours after the extubation. If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once. |
24 hours postoperatively
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Time to extubation
Periodo de tiempo: 24 hours postoperatively
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After the operation, the time until the patient is extubated will be recorded. |
24 hours postoperatively
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Length of stay in the intensive care unit.
Periodo de tiempo: Average 7 days postoperatively
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The time from admission to the intensive care unit (ICU) to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days. Total duration of stay in ICU will be recorded. |
Average 7 days postoperatively
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Assessment of Delirium
Periodo de tiempo: 24 hours postoperatively
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Delirium will be assessed using the 3-minute diagnostic Confusion Assessment Method (CAM) (acute, inattention, disorganized thinking , altered of consciousness). The diagnosis of delirium by CAM requires presence of feature 1 & 2 & either 3 or 4. Delirium using the 3-minute diagnostic Confusion Assessment Method ( acute , inattention, disorganized thinking , altered of consciousness). The diagnosis of delirium by CAM requires presence of feature 1 & 2 & either 3 or 4. It will be evaluated 24 hrs after extubation. |
24 hours postoperatively
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Level of patient satisfaction
Periodo de tiempo: 24 hours postoperatively
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Level of patient satisfaction estimated by a 5-point Likert scale (1:extremely dissatisfied; 2: unsatisfied; 3: neutral; 4: satisfied; 5: extremely satisfied). |
24 hours postoperatively
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Incidence of complications.
Periodo de tiempo: 7 days postoperatively
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Any complications-directly related to the block or the drug used in the block- will be recorded. Complications can include local anesthetic toxicity, vascular injury, pneumothorax, failed block, and anaphylactic shock. |
7 days 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
- 04-2026-300788
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Marco de tiempo para compartir IPD
After the end of study for one year.
Criterios de acceso compartido de IPD
The data will be available upon a reasonable request from the corresponding author.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
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