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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Thyroidectomy; Saliva Collection; Surgical Stress Response; Cervical Plexus Block
• Intervention / Treatment: Procedure: Ultrasound guided bilateral intermediate cervical plexus block

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Antonija Mihelčić; Phone Number: +385996830715; Email: antonijamihelcic@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: TIVA alone
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Intraoperative Sufentanyl Consumption	Unit of measure: mcg/kg/min	Intraoperative period
Total Postoperative Analgetics consumption	Unit of measure: mg	During the first 24 hours after the completion of surgery
Time to Rescue Analgesia	Unit of measure: minutes	During the first 24 hours after the completion of surgery
Hemodynamic Stability (heart rate)	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	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	The incidence of postoperative nausea and vomiting will be determined	During the first 24 hours after the completion of surgery
Hemodynamic Stability (blood pressure)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of block complication	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

Collaborators and Investigators

• Sponsor: University Hospital Dubrava

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 0119-04-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No