ThyroidectomyPhase 4NCT07740460
The Effect of Bilateral Intermediate Cervical Plexus Block on the Surgical Stress Response Following Total Thyroidectomy
A Phase 4 study testing Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine in people with Thyroidectomy and Cervical Plexus Block, run by University Hospital Dubrava.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroidectomy, Cervical Plexus Block, Surgical Stress Response
- What is being tested?
- Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 15 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or ASA II
- euthyroid status
- signed informed consent
Who cannot join
- 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
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- history of previous neck surgery or radiation
- coagulopathy
- uncontroled respiratory disease
- diabetes mellitus
- autoimune disease
- chronic corticosteroid therapy
- smokers
- pregnant women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Ultrasound-guided Bilateral Intermediate Cervical Plexus Block on Serum Biomarkers of the Surgical Stress Response Following Total Thyroidectomy
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.
Read more
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.
- Being tested
- Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% LevobupivacaineProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| TIVA alone | No intervention | Not described |
| TIVA +ultrasound-guided bilateral intermediate cervical plexus block | Experimental | Not described Receives: Procedure: Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Interleukin-6 Concentration
Unit of measure: pg/mL
Measured: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum C-reactive protein Concentration
Unit of measure: mg/L
Measured: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Total Leukocyte Count
Unit of measure: count x 10^9/L
Measured: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum Cortisol Concentration
Unit of measure: nmol/L
Measured: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum Alpha-amylase Activity
Unit of measure: U/L
Measured: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Serum Glucose Concentration
Unit of measure: mmol/L
Measured: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Secondary outcomes (6)
Total Intraoperative Sufentanyl Consumption
Unit of measure: mcg/kg/min
Measured: Intraoperative period
Total Postoperative Analgetics Consumption
Unit of measure: mg
Measured: During the first 24 hours after the completion of surgery
Time to Rescue Analgesia
Unit of measure: minutes
Measured: During the first 24 hours after the completion of surgery
Hemodynamic Stability (heart rate)
Unit of measure: beats/minute
Measured: Intraoperative period and during the first 24 hours after the completion of surgery
Hemodynamic Stability (blood pressure)
Systolic, diastolic and mean arterial pressure will be recorded during the research peroid.
Unit of measure: mmHg
Measured: Intraoperative period and during the first 24 hours after the completion of surgery
Postoperative Sedation Level
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.
Measured: During the first 4 hours after the completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonija Mihelcic, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740460
- Sponsor's protocol ID
- 0119-04-02
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-guided Bilateral Intermediate Cervical Plexus Block on Serum Biomarkers of the Surgical Stress Response Following Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT07740460
- Acronym / sponsor ID
- 0119-04-02
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA alone | No intervention | – |
| TIVA +ultrasound-guided bilateral intermediate cervical plexus block | Experimental | Procedure: Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I or ASA II
- euthyroid status
- signed informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% LevobupivacaineFollowing 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. | Procedure or surgery | TIVA +ultrasound-guided bilateral intermediate cervical plexus block |
Primary outcome
Serum Interleukin-6 Concentration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery
Unit of measure: mmol/L
6 secondary outcomes
Total Intraoperative Sufentanyl Consumption
Time frame: Intraoperative period
Total Postoperative Analgetics Consumption
Time frame: During the first 24 hours after the completion of surgery
Time to Rescue Analgesia
Time frame: During the first 24 hours after the completion of surgery
Hemodynamic Stability (heart rate)
Time frame: Intraoperative period and during the first 24 hours after the completion of surgery
Hemodynamic Stability (blood pressure)
Time frame: Intraoperative period and during the first 24 hours after the completion of surgery
Postoperative Sedation Level
Time frame: During the first 4 hours after the completion of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasound-Guided Bilateral Intermediate Cervical Plexus Block Using 0,25% Levobupivacaine in people with Thyroidectomy and Cervical Plexus Block, run by University Hospital Dubrava.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonija Mihelčić (+38512092444, antonijamihelcic@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Interleukin-6 Concentration (time frame: Baseline (preoperatively), 1 hour after the completion of surgery, 24 and 48 hours after the completion of surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.