Superficial Cervical Plexus Block With Dexmedetomidine Versus Without Adjuvant in Thyroid Surgery (BPSS-DEX)

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.

Study Overview

• Status: Completed
• Conditions: Goiter; Hyperthyroidism; Thyroid Cancer
• Intervention / Treatment: Drug: Dexmedetomidine & Bupivacaine.; Drug: Bupivacain

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80114
      • Prof. Dr. I.G.N.G Ngoerah Central General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCPB with Dexmedetomidine Adjuvant; Patients receive Superficial Cervical Plexus Block (SCPB) with Bupivacaine 0.375% and Dexmedetomidine 0.5 mcg/kgbw	Drug: Dexmedetomidine & Bupivacaine.; 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; Other Names: Bupivacaine; Dexmedetomidine; BPSS
Active Comparator: SCPB with Placebo/No Adjuvant; Patients receive Superficial Cervical Plexus Block (SCPB) with Bupivacaine 0.375% only (without Dexmedetomidine adjuvant).	Drug: Bupivacain; 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.; Other Names: Bupivacaine; BPSS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 24 hours post-operation ( 1440 minutes )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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 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.	3 months post-operation (90 days)

Collaborators and Investigators

• Sponsor: Udayana University
• Investigators: Study Chair: Lya Lusyana, dr., Universitas Udayana; Study Director: Pontisomaya Parami, Sp.An, Universitas Udayana; Study Director: I Gusti Ngurah Mahaalit Arimbawa, Sp.An, Universitas Udayana

Publications and helpful links

Helpful Links

• udayana university official website

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Pain; Chronic Pain; Dexmedetomidine; Thyroidectomy; Superficial Cervical Plexus Block; SCPB
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endocrine System Diseases; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Chronic Pain; Hyperthyroidism; Thyroid Neoplasms; Goiter; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine; Dexmedetomidine
• Other Study ID Numbers: LYA-BPSS-DEX-2025; Institutional Review Board (Other Identifier: The University of Tennessee Health Science Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No