The Effect of Ultrasound-guided Bilateral Intermediate Cervical Plexus Block on Serum Biomarkers of the Surgical Stress Response Following Total Thyroidectomy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 主要终点
- Serum Interleukin-6 Concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or ASA II
- •euthyroid status
- •signed informed consent
排除标准
- •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
- •pregnant women
研究组 & 干预措施
TIVA alone
TIVA +ultrasound-guided bilateral intermediate cervical plexus block
干预措施: Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine (Procedure)
结局指标
主要结局
Serum Interleukin-6 Concentration
时间窗: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: pg/mL
Serum C-reactive protein Concentration
时间窗: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: mg/L
Total Leukocyte Count
时间窗: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: count x 10\^9/L
Serum Cortisol Concentration
时间窗: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: nmol/L
Serum Alpha-amylase Activity
时间窗: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: U/L
Serum Glucose Concentration
时间窗: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: mmol/L
次要结局
- Total Intraoperative Sufentanyl Consumption(Intraoperative period)
- Total Postoperative Analgetics Consumption(During the first 24 hours after the completion of surgery)
- Time to Rescue Analgesia(During the first 24 hours after the completion of surgery)
- Hemodynamic Stability (heart rate)(Intraoperative period and during the first 24 hours after the completion of surgery)
- Hemodynamic Stability (blood pressure)(Intraoperative period and during the first 24 hours after the completion of surgery)
- Postoperative Sedation Level(During the first 4 hours after the completion of surgery)
研究者
Antonija Mihelcic
anesthesiologist
University Hospital Dubrava