The Effect of Bilateral Intermediate Cervical Plexus Block on the Surgical Stress Response Following Total Thyroidectomy

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Dubrava

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine

    Procedure/Surgery

    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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: TIVA aloneNo intervention 0 interventions
Group B: TIVA +ultrasound-guided bilateral intermediate cervical plexus blockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Serum Interleukin-6 Concentration

Unit of measure: pg/mL

Time frame
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
2

Serum C-reactive protein Concentration

Unit of measure: mg/L

Time frame
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
3

Total Leukocyte Count

Unit of measure: count x 10\^9/L

Time frame
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
4

Serum Cortisol Concentration

Unit of measure: nmol/L

Time frame
Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery

Secondary outcomes

1

Total Intraoperative Sufentanyl Consumption

Unit of measure: mcg/kg/min

Time frame
Intraoperative period
2

Total Postoperative Analgetics Consumption

Unit of measure: mg

Time frame
During the first 24 hours after the completion of surgery
3

Time to Rescue Analgesia

Unit of measure: minutes

Time frame
During the first 24 hours after the completion of surgery
4

Hemodynamic Stability (heart rate)

Unit of measure: beats/minute

Time frame
Intraoperative period and during the first 24 hours after the completion of surgery

Other outcomes

1

Postoperative Nausea and Vomiting

The incidence of postoperative nausea and vomiting will be determined

Time frame
During the first 24 hours after the completion of surgery
2

The Incidence of Block Complication

The incidence of possible complication of the block will be determined.

Time frame
From the administration of the block up to 48 hours after the completion of surgery

Locations

This trial has no locations.

Sponsors and contacts

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