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The Effect of Bilateral Intermediate Cervical Plexus Block on the Surgical Stress Response Following Total Thyroidectomy

4 augustus 2026 bijgewerkt door: Antonija Mihelcic, University Hospital Dubrava

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

48

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: TIVA alone
Experimenteel: TIVA +ultrasound-guided bilateral intermediate cervical plexus block
Procedure: Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Serum Interleukin-6 Concentration
Tijdsspanne: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: pg/mL
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum C-reactive protein Concentration
Tijdsspanne: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: mg/L
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Total Leukocyte Count
Tijdsspanne: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: count x 10^9/L
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum Cortisol Concentration
Tijdsspanne: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: nmol/L
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum Alpha-amylase Activity
Tijdsspanne: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: U/L
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum Glucose Concentration
Tijdsspanne: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: mmol/L
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total Intraoperative Sufentanyl Consumption
Tijdsspanne: Intraoperative period
Unit of measure: mcg/kg/min
Intraoperative period
Time to Rescue Analgesia
Tijdsspanne: 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 (blood pressure)
Tijdsspanne: 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
Total Postoperative Analgetics Consumption
Tijdsspanne: During the first 24 hours after the completion of surgery
Unit of measure: mg
During the first 24 hours after the completion of surgery
Hemodynamic Stability (heart rate)
Tijdsspanne: Intraoperative period and during the first 24 hours after the completion of surgery
Unit of measure: beats/minute
Intraoperative period and during the first 24 hours after the completion of surgery
Postoperative Sedation Level
Tijdsspanne: During the first 4 hours after the completion of surgery
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.
During the first 4 hours after the completion of surgery

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative Nausea and Vomiting
Tijdsspanne: 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
The Incidence of Block Complication
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital Dubrava

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 augustus 2026

Primaire voltooiing (Geschat)

15 maart 2027

Studie voltooiing (Geschat)

15 april 2027

Studieregistratiedata

Eerst ingediend

28 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 juli 2026

Eerst geplaatst (Werkelijk)

31 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

4 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 0119-04-02

Plan Individuele Deelnemersgegevens (IPD)

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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