About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA I or ASA II
euthyroid status
signed informed consent
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Ultrasound guided bilateral intermediate cervical plexus block
Procedure/SurgeryFollowing 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.
Treatment groups
Trial outcomes
Primary outcomes
Salivary IL-6 Concentration
Unit of measure: pg/mL
Salivary Cortisol Concentration
Unit of measure: nmol/L
Salivary Alpha-amylase Activity
Unit of measure: U/L
Secondary outcomes
Total Intraoperative Sufentanyl Consumption
Unit of measure: mcg/kg/min
Total Postoperative Analgetics consumption
Unit of measure: mg
Time to Rescue Analgesia
Unit of measure: minutes
Hemodynamic Stability (heart rate)
Heart rate will be recorded during the resaerch period. Unit of measure: beats/minute
Other outcomes
Incidence of block complication
The incidence of possible complication of the block will be determined.
Locations
Sponsors and contacts
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