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

NCT07274670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-12-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Udayana University

    lead OTHER

Principal Investigators

  • Lya Lusyana, dr. · Universitas Udayana

  • Pontisomaya Parami, Sp.An · Universitas Udayana

  • I Gusti Ngurah Mahaalit Arimbawa, Sp.An · Universitas Udayana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-10-30
Completion
2025-11-10

Countries

  • Indonesia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07274670 on ClinicalTrials.gov