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

Phase 4

Recruiting

• Conditions: Analgesia
• Interventions: Drug: Dexamethasone Phosphate; Drug: Dexmedetomidine Hydrochloride

• Registration Number: NCT05793060
• Lead Sponsor: Damanhour Teaching Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-03-31
• Study Start: 2024-01-01
• Status Verified: 2024-07
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (n=30)	Dexamethasone Phosphate	Dexamethasone group
Group A (n=30)	Dexmedetomidine Hydrochloride	Dexmedetomidine group

Primary Outcome Measures

Name	Time	Method
Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]	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)
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)	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 Outcome Measures

Name	Time	Method
Number of participants and Percentage of Drug-related side effects	24 hours after the end of the operation	Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, and Postoperative nausea and vomiting (PONV)

Trial Locations

Locations (1)

Damanhour Teaching Hospital; 🇪🇬 Damanhūr, El-Beheira, Egypt