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

January 9, 2026 updated by: Damanhour Teaching Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El-Beheira
      • Damanhūr, El-Beheira, Egypt
        • Recruiting
        • Damanhour Teaching Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (n=30)
Dexmedetomidine group
Drug: Dexmedetomidine Hydrochloride
Dexmedetomidine 50 Mcg
Other Names:
  • Precedex
Active Comparator: Group B (n=30)
Dexamethasone group
Drug: Dexamethasone Phosphate
Dexamethasone 4 mg
Other Names:
  • Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 hours after the end of the operation
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)
24 hours after the end of the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 hours after the end of the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour Teaching Hospital

Investigators

  • Principal Investigator: Ahmed M Shaat, MD, Damanhour Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTH: 23001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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