About this trial
The aim of this study is to determine the impact of ultrasound-guided bilateral intermediate cervical plexus block on the surgical stress response in patients undergoing total thyroidectomy, as measured by the concentration of stress and inflammatory biomarkers in the participants' saliva and serum.
The study will be conducted on 48 subjects divided into two groups of 24: a control group receiving total intravenous anesthesia (TIVA) and an experimental group receiving TIVA combined with a bilateral intermediate cervical plexus block.
Investigators hypothesized that a combination of bilateral intermediate cervical plexus block and total intravenous anesthesia (TIVA) would reduce the surgical stress response, as measured by salivary and blood biomarkers, compared to TIVA alone in patients undergoing total thyroidectomy.
Should the research confirm the hypothesis, it will provide an objective scientific argument for including the block in standard anesthetic protocols for total thyroidectomy surgeries, with the ultimate goal of reducing the surgical stress response and ensuring faster patient recovery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patienets of both sexes
18 years of age and older
ASA I or ASA II
euthyroid status
Disqualifiers
patients who refuse to sign the informed consent form
infection at the block injection site
hypersensitivity or contraindications to the medications used in the study
hypothyroidism or hyperthyroidism at the time of surgery
Trial design
Parallel
Treatments tested in this trial
bilateral ultrasound guided intermediate cervical plexus block with 0,25% levobupivacaine
Other interventionFollowing the induction of general anesthesia in the study group, a bilateral intermediate cervical plexus block will be performed. The subject's head is carefully turned away from the side of the neck where the block is being administered. A linear ultrasound probe is placed transversely at the midpoint of an imaginary line connecting the mastoid process and the sternal attachment of the sternocleidomastoid muscle (SCM). The cervical plexus is visualized as a small cluster of hypoechoic nodules beneath the posterolateral border of the SCM 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 is then repeated on the contralateral side.
Treatment groups
Trial outcomes
Primary outcomes
Serum Cortisol Concentration
Assessment of serum cortisol concentration as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: nmol/L
Salivary Cortisol Concentration
Assessment of salivary cortisol concentration as a biomarker of surgical stress response. Unit of measure: nmol/L
Serum IL-6 Concentration
Assessment of serum IL-6 concentration as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: pg/mL
Salivary IL-6 Concentration
Assessment of salivary IL-6 concentration as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: pg/mL
Secondary outcomes
Total Intraoperative Sufentanyl consumption
assessment of total sufentanyl consumption during surgery. Unit of measure: mcg/kg/min
Total Postoperative Analgetics Consumption
Assessment of total ketoprofen and tramadol consumption during the postoperative period. Unit of measure: mg
Time to First Rescue Analgesia
Assessment of the time elapsed from the end of surgery until the first request for rescue analgesia. Unite of measure: minutes
Postoperative Pain Intensity
Assessment of postoperative pain intensity using the visual analogue pain scale where 0 indicates no pain and 10 indicates worst possible pain. Unit of measure: 0-10
Other outcomes
The incidence of complication of the block
Sponsors and contacts
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