Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Menoufia University
- 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
received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.
Intervention: Saline (Drug)
Dexamethasone group
received 35ml levobupivacaine+8mg dexamethasone
Intervention: Dexamethasone Injection (Drug)
Dexmeteomidine group
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
ashraf magdy eskandr
Assistant Professor of Anesthesia, ICU
Menoufia University