Bilateral Ultrasound Guided Pectoralis Nerve Block Induces Hemodynamic Stability With Reducing Systemic Stress Response for Off-pump Coronary Artery Bypass Graft
6 de noviembre de 2018 actualizado por: Ahmed Said Elgebaly,MD, Tanta University
Bilateral Ultrasound Guided Pectoralis Nerve Block Induces Hemodynamic Stability With Reducing Systemic Stress Response for Adult Patients Undergoing Off-pump Coronary Artery Bypass Graft
Opioids used in attenuation of the neuroendocrine stress response in patients undergoing off-pump coronary artery bypass graft (OPCAB) it produces predictable satisfactory analgesia and sedation but with side effects such as respiratory depression, drowsiness, and myocardial depression.
Regional techniques may be encouraged to be anti-stress procedures and produce risk-free postoperative (OPCAB) period.
Pectoralis nerve block (pecs block) appears to possess a great deal of promise for patients undergoing (OPCAB) because of low complication rates as it is less invasive regional analgesic technique when compared to paravertebral, thoracic epidural analgesia and parenteral analgesia.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Aims: Ultrasound Guided Bilateral Pecs block would provide attenuation of the neuroendocrine stress response with hemodynamic profile stability, decreased analgesic consumption and improves patient postoperative outcomes after(OPCAB).
Materials and Methods: A prospective, single-blind, controlled study enrolled forty patients between the age groups of 25 and 65 years undergoing (OPCAB) through midline sternotomy under general anesthesia and randomly allocated into two groups with 20 in each group. Group 1 patients did not receive Pecs block (control group), patients were anesthetized to keep the heart rate and blood pressure within 25% of the baseline values. Whereas Group 2 patients received bilateral Pecs block preoperatively. Patients were extubated once they fulfilled extubation criteria. Heart rate, mean arterial blood pressure, Plasma levels of adrenocorticotropic hormone(ACTH) and cortisol, sufentanil consumption were determined at the following points: Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4), at the end of surgery. Ventilator duration, duration of ICU stay hospital stay were recorded postoperatively.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- Fase temprana 1
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.
Ubicaciones de estudio
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Tanta, Egipto
- Ahmed Said Elgebaly
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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
45 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- patients undergoing first-time OPCAB surgery.
- patients with good or only slightly reduced left ventricular function (ejection fraction _40%, left ventricular end-diastolic pressure _15 mmHg)
- patients below 75years of age
Exclusion Criteria:
- patients requiring CPB either electively or during the course of surgery
- patients with renal insufficiency (creatinine _1.5 mg/dL) or hepatic impairment (alanine aminotransferase or aspartate aminotransferase _40 U/mL)
- patients who misused alcohol or drugs
- patients with hemodynamic instability
- symptoms of congestive cardiac failure
- preexisting infection at the block site
- allergy to local anesthetics
- psychiatric illness
- patients with prolonged postoperative ventilator course
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: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Group 1
patients did not receive Bilateral Ultrasound Guided Pectoralis Nerve Block (control group).
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Comparador activo: Group 2
patients receive Bilateral Ultrasound Guided Pectoralis Nerve Block (control group).
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Using a 20-gauge 5 cm needle.
Injection bupivacaine 0.25% used as a local anesthetic.
The block was performed in a supine position with the arm slightly abducted.
The ultrasound probe was placed at the midclavicular level infero-laterally to locate the axillary artery and vein and then moved laterally toward the axilla until pectoralis major, pectoralis minor, and serratus anterior muscles were identified at the level of the fourth rib.
The needle was inserted in-plane with respect to the ultrasound probe.
A volume of 20 ml of local anesthetic solution was deposited in the fascial plane between pectoralis minor and serratus anterior muscle, followed by withdrawal of the needle to the fascial plane between the pectoralis major and pectoralis minor muscle, where a volume of 10 ml was deposited.
The block was performed similarly on the opposite side.
Care was taken not to cross the toxic dose of bupivacaine (3 mg/kg).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in Heart rate.
Periodo de tiempo: Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4), immediately at the end of surgery
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Ranges of heart rate will be estimated in beat per minutes.
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Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4), immediately at the end of surgery
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changes in mean arterial blood pressure and cardiac indices.
Periodo de tiempo: Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery
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Ranges of mean arterial blood pressure estimated in mmHg.
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Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery
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changes in cardiac indices.
Periodo de tiempo: Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery
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Ranges of Cardiac indices will be estimated as follow :CO in (L/min),Cl in (L/min/m2),SVR in (dyn•s/cm5) and PVR in (dyn•s/cm5).
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Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery
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changes in Plasma levels of adrenocorticotropic hormone(ACTH) .
Periodo de tiempo: Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery
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Ranges in Plasma levels of adrenocorticotropic hormone(ACTH) in (pg/mL) and cortiso in l(ng/mL)
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Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery
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changes in Plasma levels of cortisol hormone
Periodo de tiempo: Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4), immediately at the end of surgery
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Ranges in Plasma levels of cortisol in (ng/mL)
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Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4), immediately at the end of surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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changes in sufentanil consumption
Periodo de tiempo: Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery
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Measured by (µg/kg)
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Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
- Kumar KN, Kalyane RN, Singh NG, Nagaraja PS, Krishna M, Babu B, Varadaraju R, Sathish N, Manjunatha N. Efficacy of bilateral pectoralis nerve block for ultrafast tracking and postoperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):333-338. doi: 10.4103/aca.ACA_15_18.
- Froyshteter AB, Bhalla T, Tobias JD, Cambier GS, Mckee CT. Pectoralis blocks for insertion of an implantable cardioverter defibrillator in two patients with Duchenne muscular dystrophy. Saudi J Anaesth. 2018 Apr-Jun;12(2):324-327. doi: 10.4103/sja.SJA_624_17.
- Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
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 (Actual)
1 de enero de 2016
Finalización primaria (Actual)
1 de enero de 2018
Finalización del estudio (Actual)
1 de noviembre de 2018
Fechas de registro del estudio
Enviado por primera vez
31 de octubre de 2018
Primero enviado que cumplió con los criterios de control de calidad
6 de noviembre de 2018
Publicado por primera vez (Actual)
8 de noviembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de noviembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
6 de noviembre de 2018
Última verificación
1 de noviembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- TantaS
Plan de datos de participantes individuales (IPD)
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INDECISO
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
producto fabricado y exportado desde los EE. UU.
No
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