The Association Between Bilateral Intermediate Cervical Plexus Block During Total Thyroidectomy and Surgical Stress Response

NCT07600580 | Active Not Recruiting Phase 4

• 1 other identifier: 2024-0119-4
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the impact of ultrasound-guided bilateral intermediate cervical plexus block on the surgical stress response in patients undergoing total thyroidectomy, as measured by the concentration of stress and inflammatory biomarkers in the participants' saliva and serum. The study will be conducted on 48 subjects divided into two groups of 24: a control group receiving total intravenous anesthesia (TIVA) and an experimental group receiving TIVA combined with a bilateral intermediate cervical plexus block. Investigators hypothesized that a combination of bilateral intermediate cervical plexus block and total intravenous anesthesia (TIVA) would reduce the surgical stress response, as measured by salivary and blood biomarkers, compared to TIVA alone in patients undergoing total thyroidectomy. Should the research confirm the hypothesis, it will provide an objective scientific argument for including the block in standard anesthetic protocols for total thyroidectomy surgeries, with the ultimate goal of reducing the surgical stress response and ensuring faster patient recovery.

Conditions

Thyroid Cancer; Thyroid and Parathyroid Surgery; Hyperthyreosis and Goiter; Surgical Stress Response

Keywords

bilateral intermediate cervical plexus block; surgical stress response; IL-6, cortisol, alpha-amylase; saliva analysis

Outcome Measures

Primary Outcomes (9)

• Serum Cortisol Concentration

  Assessment of serum cortisol concentration as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: nmol/L

  Preoperative baseline, 1 hour postoperative, 24 hours postoperative and 48 hours postoperative

• Salivary Cortisol Concentration

  Assessment of salivary cortisol concentration as a biomarker of surgical stress response. Unit of measure: nmol/L

  Preoperative baseline, 1 hour and 24 hour postoperative

• Serum IL-6 Concentration

  Assessment of serum IL-6 concentration as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: pg/mL

  Preoperative baseline, 1 hour, 24 hours and 48 hours postoperative

• Salivary IL-6 Concentration

  Assessment of salivary IL-6 concentration as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: pg/mL

  Preoperative baseline, 1 hour and 24 hours postoperative

• Serum Alpha-amylase Activity

  Assessment of serum alpha-amylase activity as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: U/L

  Preoperative baseline, 1 hour, 24 hours and 48 hours postoperative

• Salivary Alpha-amylase Activity

  Assessment of salivary alpha-amylase activity as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: U/L

  Preoperative baseline, 1 hour and 24 hours postoperative

• Serum CRP Concentration

  Assessment of serum cortisol concentration as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: mg/L

  Preoperative baseline, 1 hour, 24 hours and 48 hours postoperative

• Serum Glucose Concentration

  Assessment of serum glucose concentration as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: mmol/L

  Preoperative baseline, 1 hour, 24 hours and 48 hours postoperative

• Total Lukocyte Count

  Assessment of total leukocyte count as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: x10\*9/L

  Preoperative baseline, 1 hour, 24 hours and 48 hours postoperative

Secondary Outcomes (7)

• Total Intraoperative Sufentanyl consumption

  Intraoperative period

• Total Postoperative Analgetics Consumption

  First 24 hours postoperative

• Time to First Rescue Analgesia

  First 24 hours postoperative

• Postoperative Pain Intensity

  15 and 30 minutes, 1,4,12,48 hours postoperative

• Hemodynamic Stability

  Intraoperative period and first 48 hours postoperative

Other Outcomes (1)

• The incidence of complication of the block

  From application of the block to 48 hours postoperatively

Study Arms (2)

total intravenous anesthesia (TIVA)

NO INTERVENTION

TIVA + bilateral intermediate cervical plexus block with 0.25% levobupivacaine

EXPERIMENTAL

Other: bilateral ultrasound guided intermediate cervical plexus block with 0,25% levobupivacaine

Interventions

bilateral ultrasound guided intermediate cervical plexus block with 0,25% levobupivacaine OTHER

Following the induction of general anesthesia in the study group, a bilateral intermediate cervical plexus block will be performed. The subject's head is carefully turned away from the side of the neck where the block is being administered. A linear ultrasound probe is placed transversely at the midpoint of an imaginary line connecting the mastoid process and the sternal attachment of the sternocleidomastoid muscle (SCM). The cervical plexus is visualized as a small cluster of hypoechoic nodules beneath the posterolateral border of the SCM 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 is then 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:

• patienets of both sexes
• years of age and older
• 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 medications used in the study
• hypothyroidism or hyperthyroidism at the time of surgery
• presence of substernal goiter
• additional surgical interventions during the procedure
• history of previous neck surgery or radiation
• coagulopathy
• uncontrolled respiratory disease
• diabetes mellitus
• autoimmune disease
• chronic corticosteroid therapy
• smokers
• pregnant women.

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University Hospital Dubrava

Zagreb, City of Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Diseases; Goiter

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases

Study Design

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

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 20, 2026
• Study Start: May 13, 2024
• Primary Completion: February 3, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-03

Locations

CR (1)