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NCT07740460
The Effect of Bilateral Intermediate Cervical Plexus Block on the Surgical Stress Response Following Total Thyroidectomy
Conditions: Thyroidectomy, Cervical Plexus Block, Surgical Stress Response
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 48
Sponsor: University Hospital Dubrava
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.
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
Source: ClinicalTrials.gov (NCT07740460). StuddyBuddy aggregates publicly available trial information.