Thyroid CancerBPSS-DEXNCT07274670
Superficial Cervical Plexus Block With Dexmedetomidine Versus Without Adjuvant in Thyroid Surgery
A study testing Dexmedetomidine & Bupivacaine. and Bupivacain in people with Thyroid Cancer and Goiter, run by Udayana University at 1 site in Indonesia.
Trial summary
Efficacy of Superficial Cervical Plexus Block (SCPB) with Dexmedetomidine Adjuvant Compared to Without Adjuvant in Thyroid Surgery. This is a double-blinded, randomized controlled trial designed to evaluate the effectiveness of adding perineural dexmedetomidine to a Superficial Cervical Plexus Block (SCPB) for pain… Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Thyroid Cancer, Goiter, Hyperthyroidism
- What is being tested?
- Dexmedetomidine & Bupivacaine. and Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2025to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 30-59 years.
- Patients with ASA physical status classification I-III.
- Patients with Body Mass Index (BMI) between 18 and 25 kg/m
Who cannot join
- Patients with contraindications for regional anesthesia.
- Patients with a history of autoimmune disease.
- Presence of infection in the puncture area.
- Patients with allergies and contraindications to the use of dexmedetomidine.
- Patients on routine medication, including beta-blockers, anti-depressants, or anti-seizure medications.
- Prolonged opioid use.
- Patients unable to be assessed using the Visual Analogue Scale (VAS) or unable to operate the Patient-Controlled Analgesia (PCA) device.
- Patients who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Prof. Dr. I.G.N.G Ngoerah Central General Hospital
Denpasar, Bali, 80114
About this study
Official title: A Randomized Double-Blind Controlled Trial on the Effectiveness of Superficial Cervical Plexus Block With Dexmedetomidine Compared to Without Adjuvant in Thyroid Surgery
Efficacy of Superficial Cervical Plexus Block (SCPB) with Dexmedetomidine Adjuvant Compared to Without Adjuvant in Thyroid Surgery. This is a double-blinded, randomized controlled trial designed to evaluate the effectiveness of adding perineural dexmedetomidine to a Superficial Cervical Plexus Block (SCPB) for pain management in patients undergoing thyroid surgery. The study aims to prove that SCPB with dexmedetomidine adjuvant provides superior post-operative analgesia, lowers total opioid consumption, prolongs the time until the first analgesic request, and reduces the incidence of chronic pain three months post-surgery compared to SCPB without the adjuvant. The study will also evaluate the anti-inflammatory effect by measuring the reduction in Interleukin-6 (IL-6) levels post-operatively and compare the incidence of bradycardia as a side effect. The total required sample size is 58 subjects.
Read the detailed description
Thyroid surgery is a major procedure often associated with acute and chronic postoperative pain in the neck area. Chronic post-surgical pain can significantly affect the patient's long-term quality of life. Superficial Cervical Plexus Block (SCPB) is an effective regional anesthesia technique used to manage perioperative pain and reduce the need for postoperative opioids. However, achieving an optimal duration of analgesia remains a challenge. Dexmedetomidine, an alpha_2-adrenergic receptor agonist, is frequently used as an adjuvant to prolong the analgesic effect of nerve blocks. Studies have shown that combining dexmedetomidine with SCPB provides better and longer-lasting analgesia. Dexmedetomidine also possesses anti-inflammatory properties, potentially lowering the level of Interleukin-6 (IL-6), a biomarker of inflammation often elevated after surgery that can exacerbate pain. The effectiveness of SCPB with dexmedetomidine adjuvant, particularly in reducing inflammation and chronic pain incidence, has not been widely explored locally at RSUP Prof. Dr. I.G.N.G. Ngoerah.Study Objectives: The primary goal is to prove the effectiveness of dexmedetomidine as an SCPB adjuvant in thyroid surgery, assessed by acute and chronic pain outcomes. Acute Pain Outcomes: Measured by Visual Analogue Scale (VAS) scores at 6, 12, and 24 hours post-operation, time to first Patient-Controlled Analgesia (PCA) button press, total opioid consumption via PCA over 24 hours, and changes in the inflammatory biomarker Interleukin-6 (IL-6). Chronic Pain Outcomes: Measured by the incidence of chronic pain three months post-surgery using the Brief Pain Inventory Short Form (BPI-SF) questionnaire. Safety Outcome: Measured by the incidence of bradycardia. Correlations: To prove the correlation between the change in Interleukin-6 levels with 24-hour pain scores and the incidence of chronic pain.Study Design and Intervention: This is a true experimental study with a double-blinded randomized pre- and post-control group design. Group P1 (Intervention): Patients receive SCPB with 0.375% Bupivacaine plus 0.5 mcg/kgbw Dexmedetomidine (total volume 20 mL, injected 10 mL on each side). Group P2 (Control): Patients receive SCPB with 0.375% Bupivacaine only (total volume 20 mL, injected 10 mL on each side).All procedures are performed under general anesthesia with Ultrasound guidance. Analgesia management includes PCA Fentanyl and combination analgesics (Paracetamol and Ibuprofen). The minimum required sample size is 58 subjects.
- Conditions
- Thyroid Cancer, Goiter, Hyperthyroidism
- Being tested
- Dexmedetomidine & Bupivacaine., Bupivacain
- Keywords
- Superficial Cervical Plexus Block, SCPB, Dexmedetomidine, Thyroidectomy, Postoperative Pain, Chronic Pain
- Medical subject headings
- Thyroid Neoplasms, Goiter, Hyperthyroidism, Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine & Bupivacaine.Drug
Also called Dexmedetomidine, Bupivacaine, BPSS
Superficial Cervical Plexus Block (SCPB) performed under ultrasound guidance (in-plane technique). The regimen consists of Bupivacaine 0.375% with the adjuvant Dexmedetomidine at a dose of 0.5 mcg/kgbw. The total volume injected is 20 mL (10 mL on each side) into the fascial space between the sternocleidomastoid muscle and the prevertebral fascia. The block is performed after induction of general anesthesia
BupivacainDrug
Also called Bupivacaine, BPSS
Superficial Cervical Plexus Block (SCPB) performed under ultrasound guidance (in-plane technique). The regimen consists of Bupivacaine 0.375% only. The total volume injected is 20 mL (10 mL on each side) [cite_start], supplemented with Saline/Placebo to match the volume and appearance of the active drug. The block is performed after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| SCPB with Dexmedetomidine Adjuvant | Experimental | Patients receive Superficial Cervical Plexus Block (SCPB) with Bupivacaine 0.375% and Dexmedetomidine 0.5 mcg/kgbw Receives: Drug: Dexmedetomidine & Bupivacaine. |
| SCPB with Placebo/No Adjuvant | Active comparator | Patients receive Superficial Cervical Plexus Block (SCPB) with Bupivacaine 0.375% only (without Dexmedetomidine adjuvant). Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Request for Opioid Analgesia (PCA Button Press)
From the time of PCA activation in the Post-Anesthesia Care Unit (PACU) until the completion of the first 24 hours post-operation. The cumulative consumption of Fentanyl (in micrograms) is recorded from the PCA device's counter, with the assessment period duration calculated precisely in minutes
Measured: up to 24 hours post-operation ( 1440 minutes )
Secondary outcomes (4)
Visual Analogue Scale (VAS) Pain Score at 6, 12, and 24 Hours Post-Operation
Assessment of acute pain intensity using the Visual Analogue Scale (VAS) (0-100 mm, where 0 is no pain and 100 is the worst pain imaginable).
Measured: 6 hours, 12 hours, and 24 hours post-operation.
Total Fentanyl Opioid Consumption in the First 24 Hours Post-Operation
The total amount of fentanyl (in mcg) consumed by the patient via the Patient-Controlled Analgesia (PCA) device.
Measured: 24 hours post-operation
Change in Interleukin-6 (IL-6) Level Post-Operation
The delta change ($\Delta$) in plasma Interleukin-6 (IL-6) concentration (in pg/mL) comparing the pre-operative baseline to the 24-hour post-operative measurement.
Measured: Measured as the difference between 24 hours post-operation and pre-general anesthesia.
Incidence of Chronic Pain at 3 Months Post-Operation
Incidence of Chronic Post-Surgical Pain (CPSP) defined by the Brief Pain Inventory Short Form (BPI-SF) score (any score > 0) lasting longer than three months.
Measured: 3 months post-operation (90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Jul 2025
- Primary completion30 Oct 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into two parallel arms with a 1:1 allocation ratio
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lya Lusyana, Udayana University
- Investigators
- Lya Lusyana, dr., Study chair, Universitas UdayanaPontisomaya Parami, Sp.An, Study director, Universitas UdayanaI Gusti Ngurah Mahaalit Arimbawa, Sp.An, Study director, Universitas Udayana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274670
- Sponsor's protocol ID
- LYA-BPSS-DEX-2025
- Other IDs
- Institutional Review Board
- Acronym
- BPSS-DEX
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 10 Dec 2025
- 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 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Controlled Trial on the Effectiveness of Superficial Cervical Plexus Block With Dexmedetomidine Compared to Without Adjuvant in Thyroid Surgery
- ClinicalTrials.gov ID
- NCT07274670
- Acronym / sponsor ID
- BPSS-DEX / LYA-BPSS-DEX-2025
- Conditions
- Thyroid Cancer, Goiter, Hyperthyroidism
- Keywords
- Superficial Cervical Plexus Block, SCPB, Dexmedetomidine, Thyroidectomy, Postoperative Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 10 Dec 2025 (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.
Efficacy of Superficial Cervical Plexus Block (SCPB) with Dexmedetomidine Adjuvant Compared to Without Adjuvant in Thyroid Surgery. This is a double-blinded, randomized controlled trial designed to evaluate the effectiveness of adding perineural dexmedetomidine to a Superficial Cervical Plexus Block (SCPB) for pain management in patients undergoing thyroid surgery. The study aims to prove that SCPB with dexmedetomidine adjuvant provides superior post-operative analgesia, lowers total opioid consumption, prolongs the time until the first analgesic request, and reduces the incidence of chronic pain three months post-surgery compared to SCPB without the adjuvant. The study will also evaluate the anti-inflammatory effect by measuring the reduction in Interleukin-6 (IL-6) levels post-operatively and compare the incidence of bradycardia as a side effect. The total required sample size is 58 subjects.
Detailed description
Thyroid surgery is a major procedure often associated with acute and chronic postoperative pain in the neck area. Chronic post-surgical pain can significantly affect the patient's long-term quality of life. Superficial Cervical Plexus Block (SCPB) is an effective regional anesthesia technique used to manage perioperative pain and reduce the need for postoperative opioids. However, achieving an optimal duration of analgesia remains a challenge. Dexmedetomidine, an alpha_2-adrenergic receptor agonist, is frequently used as an adjuvant to prolong the analgesic effect of nerve blocks. Studies have shown that combining dexmedetomidine with SCPB provides better and longer-lasting analgesia. Dexmedetomidine also possesses anti-inflammatory properties, potentially lowering the level of Interleukin-6 (IL-6), a biomarker of inflammation often elevated after surgery that can exacerbate pain. The effectiveness of SCPB with dexmedetomidine adjuvant, particularly in reducing inflammation and chronic pain incidence, has not been widely explored locally at RSUP Prof. Dr. I.G.N.G. Ngoerah.Study Objectives: The primary goal is to prove the effectiveness of dexmedetomidine as an SCPB adjuvant in thyroid surgery, assessed by acute and chronic pain outcomes. Acute Pain Outcomes: Measured by Visual Analogue Scale (VAS) scores at 6, 12, and 24 hours post-operation, time to first Patient-Controlled Analgesia (PCA) button press, total opioid consumption via PCA over 24 hours, and changes in the inflammatory biomarker Interleukin-6 (IL-6). Chronic Pain Outcomes: Measured by the incidence of chronic pain three months post-surgery using the Brief Pain Inventory Short Form (BPI-SF) questionnaire. Safety Outcome: Measured by the incidence of bradycardia. Correlations: To prove the correlation between the change in Interleukin-6 levels with 24-hour pain scores and the incidence of chronic pain.Study Design and Intervention: This is a true experimental study with a double-blinded randomized pre- and post-control group design. Group P1 (Intervention): Patients receive SCPB with 0.375% Bupivacaine plus 0.5 mcg/kgbw Dexmedetomidine (total volume 20 mL, injected 10 mL on each side). Group P2 (Control): Patients receive SCPB with 0.375% Bupivacaine only (total volume 20 mL, injected 10 mL on each side).All procedures are performed under general anesthesia with Ultrasound guidance. Analgesia management includes PCA Fentanyl and combination analgesics (Paracetamol and Ibuprofen). The minimum required sample size is 58 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized into two parallel arms with a 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| SCPB with Dexmedetomidine Adjuvant | Experimental | Drug: Dexmedetomidine & Bupivacaine.Patients receive Superficial Cervical Plexus Block (SCPB) with Bupivacaine 0.375% and Dexmedetomidine 0.5 mcg/kgbw |
| SCPB with Placebo/No Adjuvant | Active comparator | Drug: BupivacainPatients receive Superficial Cervical Plexus Block (SCPB) with Bupivacaine 0.375% only (without Dexmedetomidine adjuvant). |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 30-59 years.
- Patients with ASA physical status classification I-III.
- Patients with Body Mass Index (BMI) between 18 and 25 kg/m
Key exclusion criteria (8 listed)
- Patients with contraindications for regional anesthesia.
- Patients with a history of autoimmune disease.
- Presence of infection in the puncture area.
- Patients with allergies and contraindications to the use of dexmedetomidine.
- Patients on routine medication, including beta-blockers, anti-depressants, or anti-seizure medications.
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 |
|---|---|---|
| Dexmedetomidine & Bupivacaine.Also: Dexmedetomidine, Bupivacaine, BPSSSuperficial Cervical Plexus Block (SCPB) performed under ultrasound guidance (in-plane technique). The regimen consists of Bupivacaine 0.375% with the adjuvant Dexmedetomidine at a dose of 0.5 mcg/kgbw. The total volume injected is 20 mL (10 mL on each side) into the fascial space between the sternocleidomastoid muscle and the prevertebral fascia. The block is performed after induction of general anesthesia | Drug | SCPB with Dexmedetomidine Adjuvant |
| BupivacainAlso: Bupivacaine, BPSSSuperficial Cervical Plexus Block (SCPB) performed under ultrasound guidance (in-plane technique). The regimen consists of Bupivacaine 0.375% only. The total volume injected is 20 mL (10 mL on each side) [cite_start], supplemented with Saline/Placebo to match the volume and appearance of the active drug. The block is performed after induction of general anesthesia. | Drug | SCPB with Placebo/No Adjuvant |
Primary outcome
Time to First Request for Opioid Analgesia (PCA Button Press)
Time frame: up to 24 hours post-operation ( 1440 minutes )
From the time of PCA activation in the Post-Anesthesia Care Unit (PACU) until the completion of the first 24 hours post-operation. The cumulative consumption of Fentanyl (in micrograms) is recorded from the PCA device's counter, with the assessment period duration calculated precisely in minutes
4 secondary outcomes
Visual Analogue Scale (VAS) Pain Score at 6, 12, and 24 Hours Post-Operation
Time frame: 6 hours, 12 hours, and 24 hours post-operation.
Total Fentanyl Opioid Consumption in the First 24 Hours Post-Operation
Time frame: 24 hours post-operation
Change in Interleukin-6 (IL-6) Level Post-Operation
Time frame: Measured as the difference between 24 hours post-operation and pre-general anesthesia.
Incidence of Chronic Pain at 3 Months Post-Operation
Time frame: 3 months post-operation (90 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Udayana University Official WebsiteLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Lya Lusyana, dr. study chair
Universitas Udayana
Pontisomaya Parami, Sp.An study director
Universitas Udayana
I Gusti Ngurah Mahaalit Arimbawa, Sp.An study director
Universitas Udayana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine & Bupivacaine. and Bupivacain in people with Thyroid Cancer and Goiter, run by Udayana University at 1 site in Indonesia.
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 8 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: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Request for Opioid Analgesia (PCA Button Press) (time frame: up to 24 hours post-operation ( 1440 minutes )). 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 10 Dec 2025; AzTrials last refreshed its copy on 3 Nov 2026.