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NCT Number: NCT07721818

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.

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Key information

Conditions

Surgical Stress Response Cervical Plexus Block Saliva Collection Total Thyroidectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guided bilateral intermediate cervical plexus block

Procedure

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.

Primary outcomes

  1. Salivary IL-6 Concentration

    Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery

    Unit of measure: pg/mL

  2. Salivary Cortisol Concentration

    Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery

    Unit of measure: nmol/L

  3. Salivary Alpha-amylase Activity

    Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery

    Unit of measure: U/L

Secondary outcomes

  1. Total Intraoperative Sufentanyl Consumption

    Time frame: Intraoperative period

    Unit of measure: mcg/kg/min

  2. Total Postoperative Analgetics consumption

    Time frame: During the first 24 hours after the completion of surgery

    Unit of measure: mg

  3. Time to Rescue Analgesia

    Time frame: During the first 24 hours after the completion of surgery

    Unit of measure: minutes

  4. Hemodynamic Stability (heart rate)

    Time frame: 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

  5. Postoperative Sedation Level

    Time frame: 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.

  6. Postoperative Nausea and Vomiting

    Time frame: During the first 24 hours after the completion of surgery

    The incidence of postoperative nausea and vomiting will be determined

  7. Hemodynamic Stability (blood pressure)

    Time frame: 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

Other outcomes

  1. Incidence of block complication

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonija Mihelčić

CONTACT

[email protected]

+385996830715

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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