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

ConditionAnalgesia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-60
SponsorDamanhour Teaching Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) physical status ≤ II

Age from 21 to 60 years

Body Mass Index (BMI) ≤ 35 kg/m2

Disqualifiers

ASA physical status > II

Age < 21 years or > 50 years

BMI > 35 kg/m2

Bronchial asthma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine Hydrochloride

    Drug

    Dexmedetomidine 50 Mcg

  • Dexamethasone Phosphate

    Drug

    Dexamethasone 4 mg

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group A (n=30)Active comparator 1 intervention
Group B: Group B (n=30)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
24 hours after the end of the operation
2

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)

Time frame
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)

Time frame
24 hours after the end of the operation

Other outcomes

Sponsors and contacts

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Damanhour Teaching Hospital

Lead sponsor

Source ClinicalTrials.gov
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