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

Sponsor

Damanhour Teaching Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05793060

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Drug: Dexmedetomidine Hydrochloride Drug: Dexamethasone Phosphate	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 15, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A (n=30) Dexmedetomidine group	Drug: Dexmedetomidine Hydrochloride Dexmedetomidine 50 Mcg Other Names: Precedex
Active Comparator: Group B (n=30) Dexamethasone group	Drug: Dexamethasone Phosphate Dexamethasone 4 mg Other Names: Dexamethasone

Arm

Intervention/Treatment

Active Comparator: Group A (n=30)

Dexmedetomidine group

Drug: Dexmedetomidine Hydrochloride

Dexmedetomidine 50 Mcg

Other Names:

Precedex

Active Comparator: Group B (n=30)

Dexamethasone group

Drug: Dexamethasone Phosphate

Dexamethasone 4 mg

Other Names:

Dexamethasone

Outcome Measures

Primary Outcome Measures

Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)] [24 hours after the end of the operation]
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)
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD) [24 hours after the end of the operation]
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)

Secondary Outcome Measures

Number of participants and Percentage of Drug-related side effects [24 hours after the end of the operation]
Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, and Postoperative nausea and vomiting (PONV)