NCT05793060

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
8mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

March 17, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
2.3 years until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

January 12, 2026

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

March 17, 2023

Last Update Submit

January 9, 2026

Conditions

Analgesia

Keywords

Cervical plexus blockDexamethasoneDexmedetomidineThyroidectomy

Outcome Measures

Primary Outcomes (2)

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

    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)

    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 Outcomes (1)

  • Number of participants and Percentage of Drug-related side effects

    24 hours after the end of the operation

Study Arms (2)

Group A (n=30)

ACTIVE COMPARATOR

Dexmedetomidine group

Drug: Dexmedetomidine Hydrochloride

Group B (n=30)

ACTIVE COMPARATOR

Dexamethasone group

Drug: Dexamethasone Phosphate

Interventions

Dexmedetomidine HydrochlorideDRUG

Dexmedetomidine 50 Mcg

Also known as: Precedex
Group A (n=30)
Dexamethasone PhosphateDRUG

Dexamethasone 4 mg

Also known as: Dexamethasone
Group B (n=30)

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidinedexamethasone 21-phosphateDexamethasone

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Ahmed M Shaat, MD

    Damanhour Teaching Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Shaat, MD

CONTACT

00201223482709ahmedshaat99@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 31, 2023

Study Start

August 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

January 12, 2026

Record last verified: 2025-07

Locations

EG(1)