Efficacy and Safety of Dexmedetomidine to 20ml Bupivacaine in Supraclavicular Brachial Plexus Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Success rate.
研究概览
简要总结
The study aims to evaluate the analgesic efficacy and safety of addition of 1µg/kg dexmedetomidine to 20ml bupivacaine compared to 20ml and 30ml bupivacaine without additives in ultrasound-guided supraclavicular brachial plexus block for anesthesia.
详细描述
Dexmedetomidine, a highly selective α2 adrenergic agonist, has been used as an adjuvant to local anesthetics. Various clinical trials performed have shown dexmedetomidine to be safe when used as an adjuvant to local anesthetic in subarachnoid, caudal, and epidural Different doses of dexmedetomidine are commonly used as an additive in Ultrasound-guided supraclavicular brachial plexus block, 1 μg/kg and 2 μg/kg in which a high dose of dexmedetomidine does not prolong the duration of analgesia, but it is associated with lower heart rate and blood pressure. Incidence of hypotension and bradycardia is also more. Hence, a lower dose of 1 μg/kg dexmedetomidine is a good balance between safety and efficacy
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist (ASA) grade I or II patients
- •both sexes
- •scheduled for elective upper limb surgery below mid-humerus level under Ultrasound -guided Supraclavicular brachial plexus block .
排除标准
- •with pre-existing peripheral neuropathy of upper limb.
- •Bleeding disorders.
- •Infection at injection site.
- •Untreated pneumothorax.
- •Patients on adrenoreceptor agonist or antagonist therapy.
- •History of severe cardiac,.respiratory, hepatic, or renal disease.
- •pregnancy and known hypersensitivity to the study drugs.
研究组 & 干预措施
Bupivacaine and Dexmedetomidine
Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine.
干预措施: bupivacaine and dexmedetomidine. (Drug)
20 ml Bupivacaine without additives
Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives.
干预措施: bupivacaine only (Drug)
30 ml bupivacaine without additives
Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.
干预措施: bupivacaine (Drug)
结局指标
主要结局
Success rate.
时间窗: 30 minutes after block performance
Sensory and motor block evaluation will be done every 3 min after giving the block until complete sensory and motor block or 30 min, whichever will be earlier.
次要结局
- Pain score.(24 hours postoperative.)
- Total pethidine consumption.(24 hours postoperative.)
- Mean arterial blood pressure(From preoperatively till the end of surgery)
- Heart rate(From preoperatively till the end of surgery)
- Postoperative side effects.(24 hours postoperative)
研究者
Gamal Hendawy Shams
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Kafr-El Sheikh University
Kafrelsheikh University