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

Damanhour Teaching Hospital

Status and phase: Enrolling; Phase 4

Conditions: Analgesia

Treatments: Drug: Dexmedetomidine Hydrochloride; Drug: Dexamethasone Phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT05793060

DTH: 23001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Group A (n=30)

Active Comparator group

Description:

Dexmedetomidine group

Treatment:

Drug: Dexmedetomidine Hydrochloride

Group B (n=30)

Active Comparator group

Description:

Dexamethasone group

Treatment:

Drug: Dexamethasone Phosphate