The Effect of Bilateral Intermediate Cervical Plexus Block on the Surgical Stress Response Following Total Thyroidectomy
The Effect of Ultrasound-guided Bilateral Intermediate Cervical Plexus Block on Serum Biomarkers of the Surgical Stress Response Following Total Thyroidectomy
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Antonija Mihelčić
- 电话号码：+38512092444
- 邮箱：antonijamihelcic@yahoo.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：TIVA alone
|
|
|
实验性的：TIVA +ultrasound-guided bilateral intermediate cervical plexus block
|
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 needle tip is properly positioned within this interfascial space, roughly 2 cm medial to the insertion point, negative aspiration will be confirmed.
Subsequently, 10 mL of 0.25% levobupivacaine will be injected under direct ultrasound observation.
The identical procedure will then be performed on the contralateral side.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum Interleukin-6 Concentration
大体时间：Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
Unit of measure: pg/mL
|
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
|
Serum C-reactive protein Concentration
大体时间：Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
Unit of measure: mg/L
|
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
|
Total Leukocyte Count
大体时间：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
|
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
|
Serum Cortisol Concentration
大体时间：Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
Unit of measure: nmol/L
|
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
|
Serum Alpha-amylase Activity
大体时间：Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
Unit of measure: U/L
|
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
|
Serum Glucose Concentration
大体时间：Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
Unit of measure: mmol/L
|
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Intraoperative Sufentanyl Consumption
大体时间：Intraoperative period
|
Unit of measure: mcg/kg/min
|
Intraoperative period
|
|
Time to Rescue Analgesia
大体时间：During the first 24 hours after the completion of surgery
|
Unit of measure: minutes
|
During the first 24 hours after the completion of surgery
|
|
Hemodynamic Stability (blood pressure)
大体时间：Intraoperative period and during the first 24 hours after the completion of surgery
|
Systolic, diastolic and mean arterial pressure will be recorded during the research peroid. Unit of measure: mmHg |
Intraoperative period and during the first 24 hours after the completion of surgery
|
|
Total Postoperative Analgetics Consumption
大体时间：During the first 24 hours after the completion of surgery
|
Unit of measure: mg
|
During the first 24 hours after the completion of surgery
|
|
Hemodynamic Stability (heart rate)
大体时间：Intraoperative period and during the first 24 hours after the completion of surgery
|
Unit of measure: beats/minute
|
Intraoperative period and during the first 24 hours after the completion of surgery
|
|
Postoperative Sedation Level
大体时间：During the first 4 hours after the completion of surgery
|
Postoperative sedation level will be mesured by Richmond Agitation-Sedation Scale ranging from -5 (deepely sedated) to +4 (highly agitated), with 0 being completely alert and calm.
|
During the first 4 hours after the completion of surgery
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Nausea and Vomiting
大体时间：During the first 24 hours after the completion of surgery
|
The incidence of postoperative nausea and vomiting will be determined
|
During the first 24 hours after the completion of surgery
|
|
The Incidence of Block Complication
大体时间：From the administration of the block up to 48 hours after the completion of surgery
|
The incidence of possible complication of the block will be determined.
|
From the administration of the block up to 48 hours after the completion of surgery
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 0119-04-02
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