The Effect of Bilateral Intermediate Cervical Plexus Block on the Surgical Stress Response Following Total Thyroidectomy

The Effect of Ultrasound-guided Bilateral Intermediate Cervical Plexus Block on Serum Biomarkers of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thyroidectomy; Surgical Stress Response; Cervical Plexus Block
• Intervention / Treatment: Procedure: Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine

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

Contacts and Locations

• Study Contact: Name: Antonija Mihelčić; Phone Number: +38512092444; 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 +ultrasound-guided bilateral intermediate cervical plexus block	Procedure: Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Interleukin-6 Concentration	Unit of measure: pg/mL	Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum C-reactive protein Concentration	Unit of measure: mg/L	Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Total Leukocyte Count	Unit of measure: count x 10^9/L	Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum Cortisol Concentration	Unit of measure: nmol/L	Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum Alpha-amylase Activity	Unit of measure: U/L	Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum Glucose Concentration	Unit of measure: mmol/L	Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 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
Time to Rescue Analgesia	Unit of measure: minutes	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
Total Postoperative Analgetics Consumption	Unit of measure: mg	During the first 24 hours after the completion of surgery
Hemodynamic Stability (heart rate)	Unit of measure: beats/minute	Intraoperative period and during the first 24 hours after the completion of surgery
Postoperative Sedation Level	Postoperative sedation 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Nausea and Vomiting	The incidence of postoperative nausea and vomiting will be determined	During the first 24 hours after the completion of surgery
The 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 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): July 31, 2026

Study Record Updates

• Last Update Posted (Actual): August 7, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 0119-04-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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