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Clinical Trials/NCT03940469
NCT03940469CompletedPhase 4

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

Menoufia University1 site in 1 country60 target enrollmentStarted: July 3, 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Changes in postoperative analgesia

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts 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.

Arms & Interventions

Control group

Placebo Comparator

received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.

Intervention: Saline (Drug)

Dexamethasone group

Active Comparator

received 35ml levobupivacaine+8mg dexamethasone

Intervention: Dexamethasone Injection (Drug)

Dexmeteomidine group

Active Comparator

received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.

Intervention: Dexmedetomidine Hydrochloride (Drug)

Outcomes

Primary Outcomes

Changes in postoperative analgesia

Time Frame: 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 Outcomes

  • Postoperative analgesic requirement(During first 2 days after surgery)
  • Hemodynamic parameter(During first 2 days after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ashraf magdy eskandr

Assistant Professor of Anesthesia, ICU

Menoufia University

Study Sites (1)

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