AnalgesiaPhase 4NCT05793060
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Intermediate Cervical Plexus Block
A Phase 4 study testing Dexmedetomidine Hydrochloride and Dexamethasone Phosphate in people with Analgesia, run by Damanhour Teaching Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Dexmedetomidine Hydrochloride and Dexamethasone Phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 15 Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) ≤ 35 kg/m2
Who cannot join
- ASA physical status > II
- Age < 21 years or > 50 years
- BMI > 35 kg/m2
- Bronchial asthma
- Chronic obstructive pulmonary disease
- Restrictive lung diseases
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Damanhour Teaching Hospital
Damanhūr, El-Beheira
Ahmed M Shaat, MD, 00201223482709, ahmedshaat99@gmail.com
About this study
Official title: Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Ultrasound-guided Intermediate Cervical Plexus Block in Patients Undergoing Thyroidectomy
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.
- Conditions
- Analgesia
- Being tested
- Dexmedetomidine Hydrochloride, Dexamethasone Phosphate
- Keywords
- Cervical plexus block, Dexamethasone, Dexmedetomidine, Thyroidectomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
Also called Precedex
Dexmedetomidine 50 Mcg
Dexamethasone PhosphateDrug
Also called Dexamethasone
Dexamethasone 4 mg
| Study group | Role | What they receive |
|---|---|---|
| Group A (n=30) | Active comparator | Dexmedetomidine group Receives: Drug: Dexmedetomidine Hydrochloride |
| Group B (n=30) | Active comparator | Dexamethasone group Receives: Drug: Dexamethasone Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 24 hours after the end of the operation
Secondary outcomes (1)
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)
Measured: 24 hours after the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Aug 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damanhour Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmed M Shaat, MD, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793060
- Sponsor's protocol ID
- DTH: 23001
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No