The Association Between Bilateral Intermediate Cervical Plexus Block and Salivary Biomarkers of Surgical Stress Response Following Total Thyroidectomy
The aim of this study is to evaluate how an ultrasound-guided bilateral intermediate cervical plexus block affects the surgical stress response in individuals undergoing total thyroidectomy. The primary objective is to quantify this physiological response through the analysis of specific stress and inflammatory biomarkers collected from the participants' saliva.
The clinical trial will encompass a total of 48 patients, randomized equally into two distinct cohorts of 24 participants each. The control group will undergo standard total intravenous anesthesia (TIVA), whereas the experimental group will receive the bilateral intermediate cervical plexus block in combination with the TIVA protocol.
It is hypothesized that integrating this regional nerve block with total intravenous anesthesia will significantly attenuate the surgical stress response, evidenced by a reduction in salivary biomarker concentration, compared to utilizing TIVA alone during thyroid surgery.
Validating this hypothesis would offer robust scientific evidence to advocate for the routine integration of the bilateral intermediate cervical plexus block into standard anesthetic practices for total thyroidectomy. Ultimately, this approach aims to minimize perioperative stress and facilitate a more rapid postoperative recovery for patients.
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：+385996830715
- 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 + bilateral intermediate cervical plexus block with 0,25% levobupivacaine
|
Following the induction of general anesthesia in the study group, an ultrasound-guided bilateral intermediate cervical plexus block will be performed. The cervical plexus is visualized on the screen as a small cluster of hypoechoic nodules beneath the posterolateral border of the sternocleidomastoid muscle and immediately above the prevertebral fascia. After sterile preparation, a 22-gauge needle is inserted under ultrasound guidance in a lateromedial direction. The needle tip is positioned within the specified space, approximately 2 cm medial to the skin entry point. Following a negative aspiration test, 10 mL of 0.25% levobupivacaine is injected and visualized on the ultrasound screen. The same procedure will be repeated 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 |
|---|---|---|
|
Salivary IL-6 Concentration
大体时间：Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
Unit of measure: pg/mL
|
Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
|
Salivary Cortisol Concentration
大体时间：Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
Unit of measure: nmol/L
|
Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
|
Salivary Alpha-amylase Activity
大体时间：Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
Unit of measure: U/L
|
Baseline (preoperatively), 1 hour after the completion of surgery, and 24 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
|
|
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
|
|
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 (heart rate)
大体时间：Intraoperative period and during the first 24 hours after the completion of surgery
|
Heart rate will be recorded during the resaerch period.
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 seadtion 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
|
|
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
|
|
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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
- 0119-04-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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研究美国 FDA 监管的设备产品
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