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

Analgesia Clinical Trial

Official title:

Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Ultrasound-guided Intermediate Cervical Plexus Block in Patients Undergoing Thyroidectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05793060
• Other study ID #: DTH: 23001
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2024
• Est. completion date: February 15, 2025

Study information

• Verified date: February 2023
• Source: Damanhour Teaching Hospital
• Contact: Ahmed M Shaat, MD
• Phone: 00201223482709
• Email: ahmedshaat99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 15, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Dexmedetomidine Hydrochloride
Dexmedetomidine 50 Mcg
• Dexamethasone Phosphate
Dexamethasone 4 mg

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital	Damanhur	El-Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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