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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05793060
Enrollment
60
Registered
2023-03-31
Start date
2025-08-01
Completion date
2026-12-15
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

Keywords

Cervical plexus block, Dexamethasone, Dexmedetomidine, Thyroidectomy

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.

Interventions

DRUGDexmedetomidine Hydrochloride

Dexmedetomidine 50 Mcg

DRUGDexamethasone Phosphate

Dexamethasone 4 mg

Sponsors

Damanhour Teaching Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]24 hours after the end of the operationNPRS 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)
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)24 hours after the end of the operationNPRS 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

MeasureTime frameDescription
Number of participants and Percentage of Drug-related side effects24 hours after the end of the operationNumber of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, and Postoperative nausea and vomiting (PONV)

Countries

Egypt

Contacts

Primary ContactAhmed M Shaat, MD
ahmedshaat99@gmail.com00201223482709

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026