NCT07274670

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Udayana University · Academic / Other
• Sex: All
• Age: 30 Years – 59 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-10-30
• Completion: 2025-11-10
• First posted: 2025-12-10
• Last updated: 2025-12-10

Locations

1 site across 1 country: Indonesia