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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (n=30) | Active Comparator | Dexmedetomidine group |
|
| Group B (n=30) | Active Comparator | Dexamethasone group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine Hydrochloride | Drug | Dexmedetomidine 50 Mcg |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M Shaat, MD | Contact | 00201223482709 | ahmedshaat99@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Shaat, MD | Damanhour Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damanhour Teaching Hospital | Recruiting | Damanhūr | El-Beheira | Egypt |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| C004180 | dexamethasone 21-phosphate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dexamethasone Phosphate | Drug | Dexamethasone 4 mg |
|
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011246 |
| Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |