The Association Between Bilateral Intermediate Cervical Plexus Block and Salivary Biomarkers of Surgical Stress Response Following Total Thyroidectomy
The aim of this study is to evaluate how an ultrasound-guided bilateral intermediate cervical plexus block affects the surgical stress response in individuals undergoing total thyroidectomy. The primary objective is to quantify this physiological response through the analysis of specific stress and inflammatory biomarkers collected from the participants' saliva.
The clinical trial will encompass a total of 48 patients, randomized equally into two distinct cohorts of 24 participants each. The control group will undergo standard total intravenous anesthesia (TIVA), whereas the experimental group will receive the bilateral intermediate cervical plexus block in combination with the TIVA protocol.
It is hypothesized that integrating this regional nerve block with total intravenous anesthesia will significantly attenuate the surgical stress response, evidenced by a reduction in salivary biomarker concentration, compared to utilizing TIVA alone during thyroid surgery.
Validating this hypothesis would offer robust scientific evidence to advocate for the routine integration of the bilateral intermediate cervical plexus block into standard anesthetic practices for total thyroidectomy. Ultimately, this approach aims to minimize perioperative stress and facilitate a more rapid postoperative recovery for patients.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Antonija Mihelčić
- Número de telefone: +385996830715
- E-mail: antonijamihelcic@yahoo.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: TIVA alone
|
|
|
Experimental: TIVA + bilateral intermediate cervical plexus block with 0,25% levobupivacaine
|
Following the induction of general anesthesia in the study group, an ultrasound-guided bilateral intermediate cervical plexus block will be performed. The cervical plexus is visualized on the screen as a small cluster of hypoechoic nodules beneath the posterolateral border of the sternocleidomastoid muscle and immediately above the prevertebral fascia. After sterile preparation, a 22-gauge needle is inserted under ultrasound guidance in a lateromedial direction. The needle tip is positioned within the specified space, approximately 2 cm medial to the skin entry point. Following a negative aspiration test, 10 mL of 0.25% levobupivacaine is injected and visualized on the ultrasound screen. The same procedure will be repeated on the contralateral side. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Salivary IL-6 Concentration
Prazo: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
Unit of measure: pg/mL
|
Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
|
Salivary Cortisol Concentration
Prazo: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
Unit of measure: nmol/L
|
Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
|
Salivary Alpha-amylase Activity
Prazo: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
Unit of measure: U/L
|
Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total Intraoperative Sufentanyl Consumption
Prazo: Intraoperative period
|
Unit of measure: mcg/kg/min
|
Intraoperative period
|
|
Total Postoperative Analgetics consumption
Prazo: During the first 24 hours after the completion of surgery
|
Unit of measure: mg
|
During the first 24 hours after the completion of surgery
|
|
Time to Rescue Analgesia
Prazo: During the first 24 hours after the completion of surgery
|
Unit of measure: minutes
|
During the first 24 hours after the completion of surgery
|
|
Hemodynamic Stability (heart rate)
Prazo: Intraoperative period and during the first 24 hours after the completion of surgery
|
Heart rate will be recorded during the resaerch period.
Unit of measure: beats/minute
|
Intraoperative period and during the first 24 hours after the completion of surgery
|
|
Postoperative Sedation Level
Prazo: During the first 4 hours after the completion of surgery
|
Postoperative seadtion 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.
|
During the first 4 hours after the completion of surgery
|
|
Postoperative Nausea and Vomiting
Prazo: During the first 24 hours after the completion of surgery
|
The incidence of postoperative nausea and vomiting will be determined
|
During the first 24 hours after the completion of surgery
|
|
Hemodynamic Stability (blood pressure)
Prazo: Intraoperative period and during the first 24 hours after the completion of surgery
|
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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of block complication
Prazo: From the administration of the block up to 48 hours after the completion of surgery
|
The incidence of possible complication of the block will be determined.
|
From the administration of the block up to 48 hours after the completion of surgery
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 0119-04-01
Plano para dados de participantes individuais (IPD)
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