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NCT Number: NCT07274670

Superficial Cervical Plexus Block With Dexmedetomidine Versus 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.

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Key information

Age range

30 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Denpasar, Bali, 80114, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Dexmedetomidine, Bupivacaine, BPSS

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.

Other names: Bupivacaine, BPSS

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    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).

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

    Time frame: 24 hours post-operation

    The total amount of fentanyl (in mcg) consumed by the patient via the Patient-Controlled Analgesia (PCA) device.

  3. Change in Interleukin-6 (IL-6) Level Post-Operation

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

    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.

  4. Incidence of Chronic Pain at 3 Months Post-Operation

    Time frame: 3 months post-operation (90 days)

    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.

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Official study title

A Randomized Double-Blind Controlled Trial on the Effectiveness of Superficial Cervical Plexus Block With Dexmedetomidine Compared to Without Adjuvant in Thyroid Surgery

Acronym: BPSS-DEX

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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