Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block

Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03940469

Acronym

IBBB

Enrollment

Registered

2019-05-07

Start date

2016-07-03

Completion date

2019-01-01

Last updated

2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Analgesia, Postoperative Complications

Keywords

Dexmedetomidine, Dexamethasone, Interscalene

Brief summary

The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.

Detailed description

Sixty patients were enrolled and divided into three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. The primary outcome was the postoperative pain which was assessed by Visual analog score(VAS), the secondary outcomes were the onset and duration of sensory and motor block, the total amount of analgesic requirement, and blood cortisol level.

Interventions

DRUGSaline

2 ml normal saline

DRUGDexamethasone Injection

8 mg dexamethasone

DRUGDexmedetomidine Hydrochloride

100 microgram dexmedetomidine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

both the patients and the observer were blind to the treatment groups

Intervention model description

three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Sixty healthy patients ASA I-II * Aged 18-60 years * Of both sexes * Scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled.

Exclusion criteria

* Patients with a history of any allergic reactions to levobupivacaine, dexamethasone or α2 agonists * All patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, - Patients who were under treatment by α2 agonist or antagonists * Pregnant women * Psychiatric patients * Patients with a previous history or clinical evidence of central or peripheral neurological disease * Coagulopathy or anticoagulant/antiaggregant therapy * Contralateral phrenic nerve paresis * Patients who have an infection at the site of the block. * Every patient who had an anatomical or vascular abnormality in the upper extremity were excluded from this study.

Design outcomes

Primary

Measure	Time frame	Description
Changes in postoperative analgesia	During first 2 days after surgery	Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable).

Secondary

Measure	Time frame	Description
Postoperative analgesic requirement	During first 2 days after surgery	Total amount of paracetamol required in mg
Hemodynamic parameter	During first 2 days after surgery	Heart rate

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026