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

NCT07740460 | Not Yet Recruiting Phase 4

• 1 other identifier: 0119-04-02
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Thyroidectomy; Cervical Plexus Block; Surgical Stress Response

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• 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

• Hemodynamic Stability (blood pressure)

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

Other Outcomes (2)

• Postoperative Nausea and Vomiting

  During the first 24 hours after the completion of surgery

• The 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 +ultrasound-guided bilateral intermediate cervical plexus block

EXPERIMENTAL

Procedure: Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine

Interventions

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.

TIVA +ultrasound-guided bilateral intermediate cervical plexus block

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

+38512092444; 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: anesthesiolgist

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07