Cervical Plexus Block, Surgical Stress Response, Thyroidectomy
Conditions
Brief summary
Total thyroidectomy triggers a systemic surgical stress response involving neuroendocrine and inflammatory pathways. Ultrasound-guided bilateral intermediate cervical plexus block (BICPB) is commonly utilized for postoperative analgesia, however, its specific impact on modulating the systemic stress biomarker response remains to be fully elucidated. To evaluate the effect of an ultrasound-guided BICPB on the perioperative surgical stress response by comparing changes in specific serum inflammatory and metabolic biomarkers between patients receiving BICPB and those receiving total intravenous anesthesia (TIVA) alone. In this prospective, randomized, controlled study, a total of 48 eligible patients scheduled for elective total thyroidectomy will be randomly assigned to two groups of 24 participants each: * BICPB Group: TIVA combined with an ultrasound-guided bilateral intermediate cervical plexus block. * Control Group: TIVA alone. Venous blood samples will be collected at predefined intervals: preoperatively (baseline), immediately postoperatively, 24 hours and 48 hours post-surgery. It is hypothesized that integrating an ultrasound-guided bilateral intermediate cervical plexus block with total intravenous anesthesia (TIVA) will significantly attenuate the surgical stress response, as evidenced by a reduction in specific serum biomarker concentrations (interleukin-6, C-reactive protein, total leukocyte count,cortisol, alpha-amylase, and glucose), compared to utilizing TIVA alone during total thyroidectomy. Testing this hypothesis aims to provide scientific evidence regarding the routine integration of the bilateral intermediate cervical plexus block into standard anesthetic protocols for total thyroidectomy, with the objective of evaluating its potential to minimize perioperative stress and support postoperative patient recovery.
Interventions
PROCEDUREUltrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine
Following general anesthesia induction, patients in the study group will receive an ultrasound-guided bilateral intermediate cervical plexus block. The cervical plexus will be identified on the ultrasound screen as a small cluster of hypoechoic nodules located beneath the posterolateral border of the sternocleidomastoid muscle and superior to the prevertebral fascia. Under sterile conditions, a 22-gauge needle will be advanced lateromedially using dynamic ultrasound visualization. Once the needle tip is properly positioned within this interfascial space, roughly 2 cm medial to the insertion point, negative aspiration will be confirmed. Subsequently, 10 mL of 0.25% levobupivacaine will be injected under direct ultrasound observation. The identical procedure will then be performed 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 |
|---|---|---|
| Serum Interleukin-6 Concentration | Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery | Unit of measure: pg/mL |
| Serum C-reactive protein Concentration | Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery | Unit of measure: mg/L |
| Total Leukocyte Count | Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery | Unit of measure: count x 10\^9/L |
| Serum Cortisol Concentration | Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery | Unit of measure: nmol/L |
| Serum Alpha-amylase Activity | Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery | Unit of measure: U/L |
| Serum Glucose Concentration | Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery | Unit of measure: mmol/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 | Unit of measure: beats/minute |
| 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 |
| Postoperative Sedation Level | During the first 4 hours after the completion of surgery | Postoperative sedation 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. |
Contacts
CONTACTAntonija Mihelčić
Outcome results
None listed