Cervical Plexus Block, Saliva Collection, Surgical Stress Response, Total Thyroidectomy
Conditions
Brief summary
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.
Interventions
PROCEDUREUltrasound guided bilateral intermediate cervical plexus block
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.
Sponsors
University Hospital Dubrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary IL-6 Concentration | 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 | 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 | Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery | Unit of measure: U/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Intraoperative Sufentanyl Consumption | Intraoperative period | Unit of measure: mcg/kg/min |
| Total Postoperative Analgetics consumption | During the first 24 hours after the completion of surgery | Unit of measure: mg |
| Time to Rescue Analgesia | During the first 24 hours after the completion of surgery | Unit of measure: minutes |
| Hemodynamic Stability (heart rate) | 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 |
| Postoperative Sedation Level | 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. |
| Postoperative Nausea and Vomiting | During the first 24 hours after the completion of surgery | The incidence of postoperative nausea and vomiting will be determined |
| Hemodynamic Stability (blood pressure) | 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 |
Contacts
CONTACTAntonija Mihelčić
Outcome results
None listed