A Comparative Study Between Articaine Alone Versus Articaine Plus Dexmedetomidine for Ambulatory Orthopedic Surgery Under Supraclavicular Block
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Sensory block duration
研究概览
简要总结
Articaine has emerged as a local anesthetic (LA) that produces sensory and motor blockade shorter than bupivacaine and lower in neurotoxicity than lidocaine.
Studies have shown that adding dexmedetomidine to LA produces prolongation of sensory and motor bock duration.
Early regain of motor power with adequate analgesia is needed in ambulatory surgery, for early start of physiotherapy. This study was designed to test efficacy of adding dexmedetomidine to articaine on the duration of sensory and motor block.
详细描述
Articaine is an amide LA produced in the 1960s and first used in clinical trials in 1974. Although it is an amide that is similar to prilocaine in chemical structure, it contains a thiophene ring rather than a benzene ring. Articaine is a rapid and short acting LA, which has low neurotoxicity and appears to diffuse through tissues more readily than other commonly used LA agents. It is metabolized by nonspecific plasma esterases both in blood and tissues, leading to its rapid clearance.
α2-adrenergic receptor agonists have been the focus of interest for their sedative, analgesic, perioperative sympatholytic, and cardiovascular stabilizing effects along with providing reduction in anesthetic requirements. Dexmedetomidine may act on supraspinal (locus coeruleus) or spinal level or peripheral α2-adrenoreceptor to reduce nociceptive transmission, leading to analgesia.
Previous trials focused on adding dexmedetomidine to either levobupivacaine and bupivacaine, found augmentation of both sensory and motor block along with prolonged duration of effective analgesia. However, there remains limited knowledge of the analgesic efficacy and clinical utility of adding dexmedetomidine to articaine during peripheral nerve block in humans.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •aged 18-60 years planned for upper limb surgery below the midhumerus with an expected time of less than 90 min usually under tourniquet.
排除标准
- •allergies to local anesthetic,
- •those with ASA III and IV,
- •patients who refuse to participate,
- •uncooperative patients,
- •patients who have infection at the site of injection,
- •patients who have bleeding disorder, and patients on anticoagulant drugs.
研究组 & 干预措施
Articaine alone
supraclavicular brachial plexus block will be performed in this group guided by ultrasound. A 30 ml volume local anesthetic will be injected in the form of (29 cc articaine 2% + 1 cc isotonic saline)
干预措施: Articaine (Drug)
Articaine and Dexmedetomidine
supraclavicular brachial plexus block will be performed in this group guided by ultrasound. A 30 ml volume local anesthetic will be injected in the form of (29 cc articaine 2% + 1 cc volume of Dexmedetomidine 1 ug/kg)
干预措施: Articaine (Drug)
Articaine and Dexmedetomidine
supraclavicular brachial plexus block will be performed in this group guided by ultrasound. A 30 ml volume local anesthetic will be injected in the form of (29 cc articaine 2% + 1 cc volume of Dexmedetomidine 1 ug/kg)
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Sensory block duration
时间窗: 24 hours post block
the time between the onset of sensory block to the complete resolution of anesthesia on all nerves distribution.
次要结局
- onset time for motor block(15 minutes after block)
- motor duration block(24 hours post block)
- Analgesia time(24 hours postoperative)
- onset time of sensory block(15 minutes after block)
研究者
Samar Rafik Mohamed Amin
Assistant professor of anaesthesia and intensive care
Benha University