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

Study Overview
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Brief Summary
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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.

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

Conditions
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Analgesia

Intervention / Treatment
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* Drug: Dexmedetomidine Hydrochloride
* Drug: Dexamethasone Phosphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (n=30)<br>Dexmedetomidine group | Drug: Dexmedetomidine Hydrochloride<br>* Dexmedetomidine 50 Mcg<br>* Other names: Precedex;|
| Active Comparator: Group B (n=30)<br>Dexamethasone group | Drug: Dexamethasone Phosphate<br>* Dexamethasone 4 mg<br>* Other names: Dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical plexus block, Dexamethasone, Dexmedetomidine, Thyroidectomy