Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The Association Between Bilateral Intermediate Cervical Plexus Block and Salivary Biomarkers of Surgical Stress Response Following Total Thyroidectomy

20. juli 2026 opdateret af: Antonija Mihelcic, University Hospital Dubrava

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

48

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: TIVA alone
Eksperimentel: TIVA + bilateral intermediate cervical plexus block with 0,25% levobupivacaine
Procedure: Ultrasound guided bilateral intermediate cervical plexus block

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Salivary IL-6 Concentration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Intraoperative Sufentanyl Consumption
Tidsramme: Intraoperative period
Unit of measure: mcg/kg/min
Intraoperative period
Total Postoperative Analgetics consumption
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of block complication
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital Dubrava

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 0119-04-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Total Thyroidektomi

Kliniske forsøg med Ultrasound guided bilateral intermediate cervical plexus block

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bulgaria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner