Superficial Cervical Plexus Block With Dexmedetomidine Versus Without Adjuvant in Thyroid Surgery

NCT07274670 | Completed

• 2 other identifiers: LYA-BPSS-DEX-2025Institutional Review Board
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Thyroid Cancer; Goiter; Hyperthyroidism

Keywords

Superficial Cervical Plexus Block; SCPB; Dexmedetomidine; Thyroidectomy; Postoperative Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Visual Analogue Scale (VAS) Pain Score at 6, 12, and 24 Hours Post-Operation

  6 hours, 12 hours, and 24 hours post-operation.

• Total Fentanyl Opioid Consumption in the First 24 Hours Post-Operation

  24 hours post-operation

• Change in Interleukin-6 (IL-6) Level Post-Operation

  Measured as the difference between 24 hours post-operation and pre-general anesthesia.

• Incidence of Chronic Pain at 3 Months Post-Operation

  3 months post-operation (90 days)

Study Arms (2)

SCPB with Dexmedetomidine Adjuvant

EXPERIMENTAL

Patients receive Superficial Cervical Plexus Block (SCPB) with Bupivacaine 0.375% and Dexmedetomidine 0.5 mcg/kgbw

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).

Drug: Bupivacain

Interventions

Dexmedetomidine & Bupivacaine. DRUG

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

Also known as: Dexmedetomidine, Bupivacaine, BPSS

SCPB with Dexmedetomidine Adjuvant

Bupivacain DRUG

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.

Also known as: Bupivacaine, BPSS

SCPB with Placebo/No Adjuvant

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Prof. Dr. I.G.N.G Ngoerah Central General Hospital

Denpasar, Bali, 80114, Indonesia

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Goiter; Hyperthyroidism; Pain, Postoperative; Chronic Pain

Interventions

Dexmedetomidine; Bupivacaine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Lya Lusyana, dr.

  Universitas Udayana

  STUDY CHAIR

• Pontisomaya Parami, Sp.An

  Universitas Udayana

  STUDY DIRECTOR

• I Gusti Ngurah Mahaalit Arimbawa, Sp.An

  Universitas Udayana

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blinded study. The following measures ensure blinding: Intervention Blinding: The preparation and mixing of the local anesthetic solution (with or without Dexmedetomidine adjuvant) are performed by a third party not involved in the execution of the block or patient follow-up. The final solutions are made to look identical. Investigator/Assessor Blinding: The principal investigator and the Acute Pain Service (APS) team that performs post-operative assessments (VAS scores, opioid consumption, complications, and long-term follow-up) are blinded to the treatment group allocation (Dexmedetomidine or control). Participant Blinding: Participants are informed that the difference lies only in the adjuvant given, thus they are blinded to the specific substance received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Intensive Therapy Specialist Program Resident Doctor

Model Details: Participants are randomized into two parallel arms with a 1:1 allocation ratio

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 10, 2025
• Study Start: July 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 10, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)