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Not yet recruiting NCT07740460

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

Phase IV Interventional Thyroidectomy Cervical Plexus Block Surgical Stress Response

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 Using 0,25% Levobupivacaine.
Who it may be relevant to
Registry conditions: Thyroidectomy, Cervical Plexus Block, Surgical Stress Response. 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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Official title

The Effect of Ultrasound-guided Bilateral Intermediate Cervical Plexus Block on Serum Biomarkers of the Surgical Stress Response Following Total Thyroidectomy

Overview

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.

Interventions

  • 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 needl

Primary outcome measures

  • Serum Interleukin-6 Concentration [Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]
  • Serum C-reactive protein Concentration [Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]
  • Total Leukocyte Count [Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]
  • Serum Cortisol Concentration [Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]
  • Serum Alpha-amylase Activity [Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]
  • Serum Glucose Concentration [Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]
Secondary outcome measures (6)
  • 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]
  • Hemodynamic Stability (blood pressure) [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]

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: NCT07740460 · 0119-04-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗