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Not yet recruiting NCT07721818

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

Phase IV Interventional Surgical Stress Response Total Thyroidectomy Saliva Collection Cervical Plexus Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound guided bilateral intermediate cervical plexus block.
Who it may be relevant to
Registry conditions: Surgical Stress Response, Total Thyroidectomy, Saliva Collection, Cervical Plexus Block. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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 wit

Primary outcome measures

  • Salivary IL-6 Concentration [Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery]
  • Salivary Cortisol Concentration [Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery]
  • Salivary Alpha-amylase Activity [Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery]
Secondary outcome measures (7)
  • Total Intraoperative Sufentanyl Consumption [Time frame: Intraoperative period]
  • Total Postoperative Analgetics consumption [Time frame: During the first 24 hours after the completion of surgery]
  • Time to Rescue Analgesia [Time frame: During the first 24 hours after the completion of surgery]
  • Hemodynamic Stability (heart rate) [Time frame: Intraoperative period and during the first 24 hours after the completion of surgery]
  • Postoperative Sedation Level [Time frame: During the first 4 hours after the completion of surgery]
  • Postoperative Nausea and Vomiting [Time frame: During the first 24 hours after the completion of surgery]
  • Hemodynamic Stability (blood pressure) [Time frame: Intraoperative period and during the first 24 hours after the completion of surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07721818 · 0119-04-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗