Surgical Stress ResponsePhase 4NCT07721818
The Association Between Bilateral Intermediate Cervical Plexus Block and Salivary Biomarkers of Surgical Stress Response Following Total Thyroidectomy
A Phase 4 study testing Ultrasound guided bilateral intermediate cervical plexus block in people with Surgical Stress Response and Total Thyroidectomy, run by University Hospital Dubrava.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Stress Response, Total Thyroidectomy, Saliva Collection
- What is being tested?
- Ultrasound guided bilateral intermediate cervical plexus block
- 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
- 1 Aug 2026to 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
Show all 14Show fewer
- 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
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.
Read more
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.
- Being tested
- Ultrasound guided bilateral intermediate cervical plexus block
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 blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| TIVA alone | No intervention | Not described |
| TIVA + bilateral intermediate cervical plexus block with 0,25% levobupivacaine | Experimental | Not described Receives: Procedure: Ultrasound guided bilateral intermediate cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary IL-6 Concentration
Unit of measure: pg/mL
Measured: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
Salivary Cortisol Concentration
Unit of measure: nmol/L
Measured: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
Salivary Alpha-amylase Activity
Unit of measure: U/L
Measured: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
Secondary outcomes (7)
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)
Heart rate will be recorded during the resaerch period. Unit of measure: beats/minute
Measured: Intraoperative period and during the first 24 hours after the completion of surgery
Postoperative Sedation Level
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.
Measured: During the first 4 hours after the completion of surgery
Postoperative Nausea and Vomiting
The incidence of postoperative nausea and vomiting will be determined
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Stress ResponseStudies 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
- NCT07721818
- Sponsor's protocol ID
- 0119-04-01
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Bilateral Intermediate Cervical Plexus Block and Salivary Biomarkers of Surgical Stress Response Following Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT07721818
- Acronym / sponsor ID
- 0119-04-01
- 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
- 1 Aug 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 23 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.
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.
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 + bilateral intermediate cervical plexus block with 0,25% levobupivacaine | Experimental | Procedure: Ultrasound guided bilateral intermediate cervical plexus block |
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 blockFollowing 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. | Procedure or surgery | TIVA + bilateral intermediate cervical plexus block with 0,25% levobupivacaine |
Primary outcome
Salivary IL-6 Concentration
Time frame: 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
Time frame: 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
Time frame: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
Unit of measure: U/L
7 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
Postoperative Sedation Level
Time frame: During the first 4 hours after the completion of surgery
Postoperative Nausea and Vomiting
Time frame: 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
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 23 Jul 2026.
- Individual participant dataSharing planned: No
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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 in people with Surgical Stress Response and Total Thyroidectomy, 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 23 Jul 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 (+385996830715, antonijamihelcic@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary IL-6 Concentration (time frame: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery). The study lists 3 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 23 Jul 2026.