Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Intermediate Cervical Plexus Block
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine Hydrochloride, Dexamethasone Phosphate.
- Who it may be relevant to
- Registry conditions: Analgesia. Basic parameters: 21 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Ultrasound-guided Intermediate Cervical Plexus Block in Patients Undergoing Thyroidectomy
Overview
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
- Drug Dexmedetomidine Hydrochloride
Dexmedetomidine 50 Mcg - Drug Dexamethasone Phosphate
Dexamethasone 4 mg
Primary outcome measures
- Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)] [Time frame: 24 hours after the end of the operation]
- Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD) [Time frame: 24 hours after the end of the operation]
Secondary outcome measures (1)
- Number of participants and Percentage of Drug-related side effects [Time frame: 24 hours after the end of the operation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Damanhour Teaching Hospital — Damanhūr
Identifiers
NCT: NCT05793060 · DTH: 23001