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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07818954
Subcostal TAP Block and EEG Dynamics in Laparoscopic Cholecystectomy
Effect of Subcostal Transversus Abdominis Plane Block on Analgesia, EEG Dynamics, and Burst Suppression in Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure. Despite its minimally invasive nature, surgical stimulation and pneumoperitoneum may cause pain-related physiological and neurophysiological responses during general anesthesia.
This prospective observational study will evaluate patients undergoing laparoscopic cholecystectomy under general anesthesia. Patients will be observed according to the analgesic technique selected by the attending anesthesiologist as part of routine clinical care: intravenous remifentanil alone or remifentanil combined with an ultrasound-guided subcostal transversus abdominis plane (TAP) block.
The study will examine the relationship between the use of subcostal TAP block and intraoperative analgesic requirements, Bispectral Index (BIS) values, electroencephalographic (EEG) dynamics, and burst suppression. Postoperative pain scores, additional analgesic requirements, quality of recovery, mobilization time, length of hospital stay, and patient satisfaction will also be evaluated.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This is a prospective, single-center observational study including adult patients scheduled for laparoscopic cholecystectomy under general anesthesia. The study will be conducted at Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital.
Perioperative analgesic management will be determined by the attending anesthesiologist according to routine clinical practice and will not be assigned by the study protocol. Patients will subsequently be evaluated in two observational groups according to the analgesic technique received. One group will consist of patients receiving intravenous remifentanil infusion without a subcostal TAP block, while the other group will consist of patients receiving intravenous remifentanil infusion together with an ultrasound-guided subcostal TAP block.
General anesthesia will be maintained using sevoflurane and remifentanil according to routine clinical practice. Depth of anesthesia and cerebral electrical activity will be monitored using Bispectral Index (BIS) monitoring and electroencephalography (EEG). Intraoperative EEG characteristics, including changes in alpha-band activity and burst suppression, as well as BIS values, will be recorded and compared between the two groups.
Intraoperative analgesic consumption, including remifentanil and additional fentanyl use, will be recorded from anesthesia records. Hemodynamic responses and other routinely monitored parameters will also be documented.
Postoperative pain will be evaluated using the Numerical Rating Scale (NRS) at rest and during activity at 0, 1, 4, 8, 12, and 24 hours after surgery. Routine postoperative analgesia includes intravenous paracetamol and tenoxicam. When clinically indicated for inadequate pain control, rescue analgesia with intravenous tramadol may be administered according to routine clinical practice, and additional analgesic consumption will be recorded.
Postoperative recovery will additionally be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). Mobilization time, length of hospital stay, and patient satisfaction will also be recorded.
The primary objective of the study is to evaluate the association between subcostal TAP block use and intraoperative analgesic requirements, anesthetic depth, EEG dynamics, and burst suppression. Secondary objectives include comparison of postoperative pain, additional analgesic consumption, quality of recovery, mobilization time, length of hospital stay, and patient satisfaction between the two groups.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Reclutamiento
- Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
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Contacto:
- Department of Anesthesiology and Reanimation, MD
- Número de teléfono: +90 216 606 33 00
- Correo electrónico: sancaktepeetikkurul@gmail.com
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Contacto:
- Ezgi Erdag, MD
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Investigador principal:
- Nurten Bakan
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age 18 years or older
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled to undergo laparoscopic cholecystectomy under general anesthesia
- Written informed consent provided by the participant or, when applicable, the legally authorized representative
Exclusion Criteria:
- Refusal to participate in the study
- American Society of Anesthesiologists (ASA) physical status IV-V
- Known allergy or hypersensitivity to medications used during perioperative anesthetic or analgesic management
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Remifentanil Group
Patients receiving intravenous remifentanil infusion without a subcostal TAP block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.
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Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.
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Remifentanil + Subcostal TAP Block Group
Patients receiving intravenous remifentanil infusion together with an ultrasound-guided subcostal transversus abdominis plane (TAP) block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.
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Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.
Ultrasound-guided subcostal transversus abdominis plane block performed as part of routine perioperative analgesic management according to the attending anesthesiologist's clinical decision.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total Intraoperative Remifentanil Consumption
Periodo de tiempo: From induction of general anesthesia until the end of surgery
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Total amount of intravenous remifentanil administered during laparoscopic cholecystectomy will be recorded from the anesthesia record and compared between the remifentanil-only group and the remifentanil plus subcostal TAP block group.
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From induction of general anesthesia until the end of surgery
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Intraoperative Bispectral Index Values
Periodo de tiempo: From induction of general anesthesia until the end of surgery
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Bispectral Index (BIS) values recorded during general anesthesia will be evaluated to assess anesthetic depth and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
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Intraoperative EEG Alpha-Band Activity
Periodo de tiempo: From induction of general anesthesia until the end of surgery
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Changes in electroencephalographic alpha-band activity during general anesthesia and surgical stimulation will be recorded and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
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Intraoperative Burst Suppression
Periodo de tiempo: From induction of general anesthesia until the end of surgery
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Burst suppression observed on intraoperative EEG monitoring during general anesthesia will be recorded and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Intraoperative Fentanyl Consumption
Periodo de tiempo: From induction of general anesthesia until the end of surgery
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The total dose of intravenous fentanyl administered during laparoscopic cholecystectomy will be recorded from the anesthesia record and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
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Postoperative Pain at Rest
Periodo de tiempo: At 0, 1, 4, 8, 12, and 24 hours after surgery
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Pain intensity at rest will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measurements will be recorded at 0, 1, 4, 8, 12, and 24 hours after surgery.
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At 0, 1, 4, 8, 12, and 24 hours after surgery
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Postoperative Pain During Activity
Periodo de tiempo: At 0, 1, 4, 8, 12, and 24 hours after surgery
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Pain intensity during activity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measurements will be recorded at 0, 1, 4, 8, 12, and 24 hours after surgery.
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At 0, 1, 4, 8, 12, and 24 hours after surgery
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Total Postoperative Rescue Tramadol Consumption
Periodo de tiempo: During the first 24 hours after surgery
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The total dose of intravenous tramadol administered as rescue analgesia for postoperative pain with an NRS score of 4 or greater will be recorded.
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During the first 24 hours after surgery
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Quality of Recovery-15 Score
Periodo de tiempo: At 24 hours after surgery
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Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15).
The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
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At 24 hours after surgery
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Time to First Mobilization
Periodo de tiempo: Up to 24 hours after surgery
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The time from completion of surgery to the patient's first postoperative mobilization will be recorded.
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Up to 24 hours after surgery
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Length of Hospital Stay
Periodo de tiempo: From completion of surgery until hospital discharge Up to 7 days
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The duration of postoperative hospital stay will be recorded and compared between the two observational groups.
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From completion of surgery until hospital discharge Up to 7 days
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Anders M, Anders B, Dreismickenbecker E, Hight D, Kreuzer M, Walter C, Zinn S. EEG responses to standardised noxious stimulation during clinical anaesthesia: a pilot study. BJA Open. 2022 Dec 30;5:100118. doi: 10.1016/j.bjao.2022.100118. eCollection 2023 Mar.
- MacKay EC, Sleigh JW, Voss LJ, Barnard JP. Episodic waveforms in the electroencephalogram during general anaesthesia: a study of patterns of response to noxious stimuli. Anaesth Intensive Care. 2010 Jan;38(1):102-12. doi: 10.1177/0310057X1003800118.
- Bublitz V, Jurth C, Kreuzer M, Lichtner G, von Dincklage F. Electroencephalogram-based prediction and detection of responsiveness to noxious stimulation in critical care patients: a retrospective single-centre analysis. Br J Anaesth. 2023 Feb;130(2):e339-e350. doi: 10.1016/j.bja.2022.09.031. Epub 2022 Nov 19.
- Garcia PS, Kreuzer M, Hight D, Sleigh JW. Effects of noxious stimulation on the electroencephalogram during general anaesthesia: a narrative review and approach to analgesic titration. Br J Anaesth. 2021 Feb;126(2):445-457. doi: 10.1016/j.bja.2020.10.036.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
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
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Complicaciones Postoperatorias
- Procesos Patológicos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor Postoperatorio
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Ácidos, acíclico
- Ácidos carboxílicos
- Piperidinas
- Propionios
- Remifentanilo
Otros números de identificación del estudio
- TAPEEG-LC-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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