Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in postoperative analgesia
研究概览
简要总结
The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
both the patients and the observer were blind to the treatment groups
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sixty healthy patients ASA I-II
- •Aged 18-60 years
- •Of both sexes
- •Scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled.
排除标准
- •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.
研究组 & 干预措施
Control group
received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.
干预措施: Saline (Drug)
Dexamethasone group
received 35ml levobupivacaine+8mg dexamethasone
干预措施: Dexamethasone Injection (Drug)
Dexmeteomidine group
received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
干预措施: Dexmedetomidine Hydrochloride (Drug)
结局指标
主要结局
Changes in postoperative analgesia
时间窗: 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).
次要结局
- Postoperative analgesic requirement(During first 2 days after surgery)
- Hemodynamic parameter(During first 2 days after surgery)
研究者
ashraf magdy eskandr
Assistant Professor of Anesthesia, ICU
Menoufia University