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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Serum Interleukin-6 Concentration [Срок оценки: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]
• Serum C-reactive protein Concentration [Срок оценки: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]
• Total Leukocyte Count [Срок оценки: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]
• Serum Cortisol Concentration [Срок оценки: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]
• Serum Alpha-amylase Activity [Срок оценки: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]
• Serum Glucose Concentration [Срок оценки: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery]

Вторичные конечные точки (6)

• Total Intraoperative Sufentanyl Consumption [Срок оценки: Intraoperative period]
• Total Postoperative Analgetics Consumption [Срок оценки: During the first 24 hours after the completion of surgery]
• Time to Rescue Analgesia [Срок оценки: During the first 24 hours after the completion of surgery]
• Hemodynamic Stability (heart rate) [Срок оценки: Intraoperative period and during the first 24 hours after the completion of surgery]
• Hemodynamic Stability (blood pressure) [Срок оценки: Intraoperative period and during the first 24 hours after the completion of surgery]
• Postoperative Sedation Level [Срок оценки: During the first 4 hours after the completion of surgery]

Критерии участия

Критерии включения

• ASA I or ASA II
• euthyroid status
• signed informed consent

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07740460 · 0119-04-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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