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NCT Number: NCT05793060

Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Intermediate Cervical Plexus Block

Background: Many thyroidectomy patients suffer from postoperative pain that could delay early hospital discharge and place a significant burden on both the patient and the healthcare team. Bilateral intermediate cervical plexus block (ICPB) provides good analgesia for neck surgery, including thyroidectomy. However, the duration of a single-shot nerve block is usually short. Therefore, adjuvants are used in peripheral nerve blocks.

Objectives: To compare the safety and efficacy of dexmedetomidine versus dexamethasone as adjuvants to bupivacaine in ultrasound-guided intermediate cervical plexus block in patients undergoing total thyroidectomy under general anesthesia.

Patients and Methods: This is a randomized, double-blind, phase four, prospective clinical trial; carried out on 60 patients, who were candidates for total thyroidectomy under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received bilateral ICPB with isobaric bupivacaine plus dexmedetomidine, and group B, received bilateral ICPB with isobaric bupivacaine plus dexamethasone.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Location status: Recruiting

Location contact

Ahmed M Shaat, MD

CONTACT

[email protected]

00201223482709

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status ≤ II
  • Age from 21 to 60 years
  • Body Mass Index (BMI) ≤ 35 kg/m2

Exclusion criteria

  • ASA physical status > II
  • Age < 21 years or > 50 years
  • BMI > 35 kg/m2
  • Bronchial asthma
  • Chronic obstructive pulmonary disease
  • Restrictive lung diseases
  • Sick sinus syndrome
  • Sinus bradycardia
  • Hypertension
  • Chronic hypotension
  • Ischemic heart disease
  • Coagulopathies
  • Hepatic insufficiency
  • Renal insufficiency
  • Diabetes mellitus
  • Peripheral neuropathy
  • Thyroid malignancy
  • Hyperthyroidism
  • Substernal goiter
  • Patients on beta-blockers
  • Patients using pacemakers
  • Alcohol or drug abuse
  • Allergy to the study drugs

Treatment and study plan

Dexmedetomidine Hydrochloride

Drug

Dexmedetomidine 50 Mcg

Other names: Precedex

Dexamethasone phosphate

Drug

Dexamethasone 4 mg

Other names: Dexamethasone

Primary outcomes

  1. Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]

    Time frame: 24 hours after the end of the operation

    NPRS measures the severity of pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain ( At post anesthesia care unit (PACU), then every 2 hours till 24 hours)

  2. Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)

    Time frame: 24 hours after the end of the operation

    NPRS measures the severity of pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain ( At PACU, then every 2 hours till 24 hours)

Secondary outcomes

  1. Number of participants and Percentage of Drug-related side effects

    Time frame: 24 hours after the end of the operation

    Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, and Postoperative nausea and vomiting (PONV)

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed M Shaat, MD

CONTACT

[email protected]

00201223482709

Sponsors and collaborators

Lead sponsor

Damanhour Teaching Hospital

Other Gov

Registry information

Official study title

Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Ultrasound-guided Intermediate Cervical Plexus Block in Patients Undergoing Thyroidectomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2023
Registry last updated
Jan 12, 2026

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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