The Effect of Bilateral Intermediate Cervical Plexus Block on the Surgical Stress Response Following Total Thyroidectomy
The Effect of Ultrasound-guided Bilateral Intermediate Cervical Plexus Block on Serum Biomarkers of the Surgical Stress Response Following Total Thyroidectomy
Total thyroidectomy triggers a systemic surgical stress response involving neuroendocrine and inflammatory pathways. Ultrasound-guided bilateral intermediate cervical plexus block (BICPB) is commonly utilized for postoperative analgesia, however, its specific impact on modulating the systemic stress biomarker response remains to be fully elucidated.
To evaluate the effect of an ultrasound-guided BICPB on the perioperative surgical stress response by comparing changes in specific serum inflammatory and metabolic biomarkers between patients receiving BICPB and those receiving total intravenous anesthesia (TIVA) alone.
In this prospective, randomized, controlled study, a total of 48 eligible patients scheduled for elective total thyroidectomy will be randomly assigned to two groups of 24 participants each:
- BICPB Group: TIVA combined with an ultrasound-guided bilateral intermediate cervical plexus block.
- Control Group: TIVA alone.
Venous blood samples will be collected at predefined intervals: preoperatively (baseline), immediately postoperatively, 24 hours and 48 hours post-surgery.
It is hypothesized that integrating an ultrasound-guided bilateral intermediate cervical plexus block with total intravenous anesthesia (TIVA) will significantly attenuate the surgical stress response, as evidenced by a reduction in specific serum biomarker concentrations (interleukin-6, C-reactive protein, total leukocyte count,cortisol, alpha-amylase, and glucose), compared to utilizing TIVA alone during total thyroidectomy.
Testing this hypothesis aims to provide scientific evidence regarding the routine integration of the bilateral intermediate cervical plexus block into standard anesthetic protocols for total thyroidectomy, with the objective of evaluating its potential to minimize perioperative stress and support postoperative patient recovery.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Antonija Mihelčić
- Número de teléfono: +38512092444
- Correo electrónico: antonijamihelcic@yahoo.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- ASA I or ASA II
- euthyroid status
- signed informed consent
Exclusion Criteria:
- patients who refuse to sign the informed consent form
- infection at the block injection site
- hypersensitivity or contraindications to the medication used in the study
- hypo/hyperthyroidism at the time of surgery
- presence of substernal goiter
- additional surgical interventions during the procedure
- history of previous neck surgery or radiation
- coagulopathy
- uncontroled respiratory disease
- diabetes mellitus
- autoimune disease
- chronic corticosteroid therapy
- smokers
- pregnant women
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: TIVA alone
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Experimental: TIVA +ultrasound-guided bilateral intermediate cervical plexus block
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Following general anesthesia induction, patients in the study group will receive an ultrasound-guided bilateral intermediate cervical plexus block.
The cervical plexus will be identified on the ultrasound screen as a small cluster of hypoechoic nodules located beneath the posterolateral border of the sternocleidomastoid muscle and superior to the prevertebral fascia.
Under sterile conditions, a 22-gauge needle will be advanced lateromedially using dynamic ultrasound visualization.
Once the needle tip is properly positioned within this interfascial space, roughly 2 cm medial to the insertion point, negative aspiration will be confirmed.
Subsequently, 10 mL of 0.25% levobupivacaine will be injected under direct ultrasound observation.
The identical procedure will then be performed on the contralateral side.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Serum Interleukin-6 Concentration
Periodo de tiempo: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
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Unit of measure: pg/mL
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Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
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Serum C-reactive protein Concentration
Periodo de tiempo: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
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Unit of measure: mg/L
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Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
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Total Leukocyte Count
Periodo de tiempo: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
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Unit of measure: count x 10^9/L
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Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
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Serum Cortisol Concentration
Periodo de tiempo: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
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Unit of measure: nmol/L
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Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
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Serum Alpha-amylase Activity
Periodo de tiempo: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
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Unit of measure: U/L
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Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
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Serum Glucose Concentration
Periodo de tiempo: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
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Unit of measure: mmol/L
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Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Intraoperative Sufentanyl Consumption
Periodo de tiempo: Intraoperative period
|
Unit of measure: mcg/kg/min
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Intraoperative period
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Time to Rescue Analgesia
Periodo de tiempo: During the first 24 hours after the completion of surgery
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Unit of measure: minutes
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During the first 24 hours after the completion of surgery
|
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Hemodynamic Stability (blood pressure)
Periodo de tiempo: Intraoperative period and during the first 24 hours after the completion of surgery
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Systolic, diastolic and mean arterial pressure will be recorded during the research peroid. Unit of measure: mmHg |
Intraoperative period and during the first 24 hours after the completion of surgery
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Total Postoperative Analgetics Consumption
Periodo de tiempo: During the first 24 hours after the completion of surgery
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Unit of measure: mg
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During the first 24 hours after the completion of surgery
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Hemodynamic Stability (heart rate)
Periodo de tiempo: Intraoperative period and during the first 24 hours after the completion of surgery
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Unit of measure: beats/minute
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Intraoperative period and during the first 24 hours after the completion of surgery
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Postoperative Sedation Level
Periodo de tiempo: During the first 4 hours after the completion of surgery
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Postoperative sedation level will be mesured by Richmond Agitation-Sedation Scale ranging from -5 (deepely sedated) to +4 (highly agitated), with 0 being completely alert and calm.
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During the first 4 hours after the completion of surgery
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative Nausea and Vomiting
Periodo de tiempo: During the first 24 hours after the completion of surgery
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The incidence of postoperative nausea and vomiting will be determined
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During the first 24 hours after the completion of surgery
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The Incidence of Block Complication
Periodo de tiempo: From the administration of the block up to 48 hours after the completion of surgery
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The incidence of possible complication of the block will be determined.
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From the administration of the block up to 48 hours after the completion of surgery
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Colaboradores e Investigadores
Patrocinador
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
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
Otros números de identificación del estudio
- 0119-04-02
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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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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