Clinical trial NCT05793060: Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Intermediate Cervical Plexus Block
Official title: Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Ultrasound-guided Intermediate Cervical Plexus Block in Patients Undergoing Thyroidectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Analgesia
Keywords: Cervical plexus block
Dexamethasone
Dexmedetomidine
Thyroidectomy
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
timeFrame: 24 hours after the end of the operation
measure: Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
timeFrame: 24 hours after the end of the operation
Secondary outcomes:
measure: Number of participants and Percentage of Drug-related side effects
timeFrame: 24 hours after the end of the operation
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat, MD
role: PRINCIPAL_INVESTIGATOR
References: