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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Antonija Mihelčić
- 電話番号：+385996830715
- メール：antonijamihelcic@yahoo.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：TIVA alone
|
|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Salivary IL-6 Concentration
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Intraoperative Sufentanyl Consumption
時間枠：Intraoperative period
|
Unit of measure: mcg/kg/min
|
Intraoperative period
|
|
Total Postoperative Analgetics consumption
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of block complication
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 0119-04-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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