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NCT Number: NCT07740460

The Effect of Bilateral Intermediate Cervical Plexus Block on 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.

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Key information

Conditions

Thyroidectomy Cervical Plexus Block Surgical Stress Response

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 Using 0,25% Levobupivacaine

Procedure

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.

Primary outcomes

  1. Serum Interleukin-6 Concentration

    Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery

    Unit of measure: pg/mL

  2. Serum C-reactive protein Concentration

    Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery

    Unit of measure: mg/L

  3. Total Leukocyte Count

    Time frame: 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

  4. Serum Cortisol Concentration

    Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery

    Unit of measure: nmol/L

  5. Serum Alpha-amylase Activity

    Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery

    Unit of measure: U/L

  6. Serum Glucose Concentration

    Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery

    Unit of measure: mmol/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

    Unit of measure: beats/minute

  5. 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

  6. 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.

Other outcomes

  1. 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

  2. The 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]

+38512092444

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Official study title

The Effect of Ultrasound-guided Bilateral Intermediate Cervical Plexus Block on Serum Biomarkers of the Surgical Stress Response Following Total Thyroidectomy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 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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