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

NCT07721818 | Not Yet Recruiting Phase 4

• 1 other identifier: 0119-04-01
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Surgical Stress Response; Total Thyroidectomy; Saliva Collection; Cervical Plexus Block

Outcome Measures

Primary Outcomes (3)

• Salivary IL-6 Concentration

  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

  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

  Unit of measure: U/L

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

Secondary Outcomes (7)

• Total Intraoperative Sufentanyl Consumption

  Intraoperative period

• Total Postoperative Analgetics consumption

  During the first 24 hours after the completion of surgery

• Time to Rescue Analgesia

  During the first 24 hours after the completion of surgery

• Hemodynamic Stability (heart rate)

  Intraoperative period and during the first 24 hours after the completion of surgery

• Postoperative Sedation Level

  During the first 4 hours after the completion of surgery

Other Outcomes (1)

• Incidence of block complication

  From the administration of the block up to 48 hours after the completion of surgery

Study Arms (2)

TIVA alone

NO INTERVENTION

TIVA + bilateral intermediate cervical plexus block with 0,25% levobupivacaine

EXPERIMENTAL

Procedure: Ultrasound guided bilateral intermediate cervical plexus block

Interventions

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.

TIVA + bilateral intermediate cervical plexus block with 0,25% levobupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I or ASA II
• euthyroid status
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Dubrava: lead

Central Study Contacts

Antonija Mihelčić

CONTACT

+385996830715; antonijamihelcic@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share