- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07916558
Impact of Parasternal and Rectointercostal Blocks on Extubation Time
"The Effect of Ultrasound-Guided Parasternal and Rectointercostal Block Application on Postoperative Extubation Timing in Open Heart Surgery: A 2-Year Retrospective Cohort Study"
"Postoperative pain constitutes a major recovery challenge in patients undergoing open-heart surgery with median sternotomy and chest tube insertion (subxiphoid/intercostal). This study aimed to evaluate the effect of parasternal and rectointercostal block administration-performed to achieve pain control and reduce the postoperative analgesic burden-on patient postoperative recovery and extubation time."
Descripción general del estudio
Estado
Condiciones
Descripción detallada
"Median sternotomy performed in open-heart surgery causes severe anterior chest wall pain in the postoperative period. This pain leads to inadequate inspiration, suppression of the cough reflex, atelectasis, and increased pulmonary complications. On the other hand, traditionally used high-dose opioid-based analgesia regimens delay the extubation process by causing respiratory depression, nausea, sedation, and impaired intestinal motility.
In current cardiac anesthesia practice, the primary goal is to reduce opioid consumption through multimodal analgesia approaches, enable early extubation (fast-track cardiac anesthesia), and shorten the duration of intensive care unit stay.
Median sternotomy performed in open-heart surgery causes severe anterior chest wall pain in the postoperative period. This pain leads to inadequate inspiration, suppression of the cough reflex, atelectasis, and an increase in pulmonary complications. On the other hand, traditionally used high-dose opioid-based analgesia regimens delay the extubation process by causing respiratory depression, nausea, sedation, and gastrointestinal motility disorders.
In current cardiac anesthesia practice, the primary goal is to reduce opioid consumption through multimodal analgesia approaches, enable early extubation (fast-track cardiac anesthesia), and shorten the length of stay in the intensive care unit.
Parasternal block (parasternal intercostal block or pectoral/parasternal fascial plane blocks) targets the anterior cutaneous branches of T2-T6 spinal nerves, providing potent analgesia around the sternum and internal mammary area. Studies in the literature demonstrate that bilateral parasternal block performed under ultrasonography (USG) guidance significantly controls somatic pain related to sternotomy incision.
Rectointercostal fascial plane block blocks the anterior and lateral cutaneous branches of T6-T9 intercostal nerves. It provides somatic analgesia in the epigastric region, subxiphoid incision lines, and the lower border of the anterior abdominal/chest wall. It specifically blocks the sharp pain at the subxiphoid chest tube (drain) insertion sites-which are not covered by the parasternal block applied for median sternotomy in open-heart surgery-and the discomfort during tube removal.
Opioid Sparing and Pulmonary Functions: Randomized controlled trials have reported that blocks administered intraoperatively or at the end of surgery reduce total postoperative 24-hour opioid (fentanyl, morphine, tramadol) consumption by 30% to 50%. Decreased opioid requirement improves the recovery quality of patients by minimizing systemic side effects.
Extubation Time: Optimization of analgesia ensures the maintenance of patient chest wall compliance and tidal volume. Literature shows that patients receiving blocks reach weaning criteria faster once normothermia and hemodynamic stability are achieved, and their mean extubation times are significantly shorter compared to control groups.
Although prospective studies exist in the literature, retrospective cohort analyses investigating the impact of clinical routine practice on extubation times and reflecting real-world data are needed.
For this purpose, patients who underwent open-heart surgery in our clinic during a 2-year period (2024-2025) will be screened to investigate the effect of block applications on extubation times.
"Patients' age, sex, BMI, presence of comorbidities, ejection fraction, duration of surgery, cardiopulmonary bypass time, cross-clamp time, extubation time, administration of rescue analgesia, Visual Analog Scale (VAS) score at extubation, EuroSCORE II, and length of intensive care unit (ICU) stay will be recorded.
The primary endpoint was determined as meeting the weaning criteria and achieving successful extubation.
The secondary endpoint was determined as discharge from the intensive care unit
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: GÖKÇE ÜLTAN ÖZGEN
- Número de teléfono: 05067750245
- Correo electrónico: gokceozgen55@gmail.com
Ubicaciones de estudio
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Samsun, Turquía (Türkiye)
- Samsun City Hospital
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Contacto:
- mehmet gökhan taflan
- Número de teléfono: 05352114070
- Correo electrónico: drmehmettaflan@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
"Patients who underwent open-heart surgery in our clinic during the period of 2024-2025
Descripción
Inclusion Criteria:
- Patients undergoing elective CABG or valve surgery
- Patients with median sternotomy and chest tube/drain placement
- Patients with complete anesthesia and intensive care unit follow-up records
Exclusion Criteria:
- Patients undergoing emergency surgery or reoperation
- Patients who could not be extubated for more than 24 hours
- Patients with missing medical record or follow-up data
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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NERVE BLOCK GROUP
"Patients who underwent ultrasound-guided parasternal and rectointercostal block for postoperative analgesia. |
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Standard Analgesia Group
"Patients followed up with routine postoperative analgesics without receiving any nerve block." |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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POSTOPERATİVE EXTUBATİON TİME
Periodo de tiempo: Within the first 24-48 hours postoperatively
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The primary result measure is the extubation period recorded as the time from the patient's arrival at the intensive care unit to successful extubation. |
Within the first 24-48 hours postoperatively
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Visual Analog Scale (VAS) Pain Score at 30 Minutes Post-Extubation
Periodo de tiempo: postoperative 30th minute
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"Assessment of postoperative pain intensity using the Visual Analog Scale (ranging from 0 to 10) 30 minutes following tracheal extubation |
postoperative 30th minute
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Visual Analog Scale (VAS) Pain Score at 2 Hours Post-Extubation
Periodo de tiempo: postoperative 2nd hour
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Assessment of postoperative pain intensity using the Visual Analog Scale (ranging from 0 to 10) 2 hours following tracheal extubation. |
postoperative 2nd hour
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.
- Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.
- Pascarella G, Costa F, Nonnis G, Strumia A, Sarubbi D, Schiavoni L, Di Pumpo A, Mortini L, Grande S, Attanasio A, Gadotti G, De Cassai A, Mattei A, Nenna A, Chello M, Cataldo R, Agro FE, Carassiti M. Ultrasound Guided Parasternal Block for Perioperative Analgesia in Cardiac Surgery: A Prospective Study. J Clin Med. 2023 Mar 6;12(5):2060. doi: 10.3390/jcm12052060.
- Huang Y, Hong M, Mao Q, Liang D, Liu G, Huang M, Zhong H, Lu Y, Zhong Y, Chen Y. Impact of liposomal bupivacaine parasternal block combined with rectus sheath block on postoperative pain in patients undergoing sternotomy for cardiac surgery: a randomized controlled trial. BMC Anesthesiol. 2026 Jun 17;26(1):533. doi: 10.1186/s12871-026-03903-y.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GOKAEK 2026/20/7
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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