The Association Between Bilateral Intermediate Cervical Plexus Block and Salivary Biomarkers of 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
- Salivary IL-6 Concentration
研究概览
简要总结
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 + bilateral intermediate cervical plexus block with 0,25% levobupivacaine
干预措施: Ultrasound guided bilateral intermediate cervical plexus block (Procedure)
结局指标
主要结局
Salivary IL-6 Concentration
时间窗: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
Unit of measure: pg/mL
Salivary Cortisol Concentration
时间窗: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
Unit of measure: nmol/L
Salivary Alpha-amylase Activity
时间窗: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
Unit of measure: U/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)
- Postoperative Sedation Level(During the first 4 hours after the completion of surgery)
- Postoperative Nausea and Vomiting(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)
研究者
Antonija Mihelcic
Anesthesiologist
University Hospital Dubrava