The Motor Effect of 0.25%Bupivacaine Ultrasound Guided Axillary Block Versus 0.19% Bupivacaine Ultrasound Guided Axillary Block in Pediatrics Undergoing Below Elbow Orthopedic Surgeries: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Motor power using modified bromage scale on admission to the PACU (post anesthesia care unit)
研究概览
简要总结
Postoperative pain is a common manifestation in orthopedic patients, mainly due to intraoperative tissue damage and inadequate intraoperative pain assessment and management .Axillary brachial plexus block provides motor and sensory block with the distribution of the median, radial, ulnar and musculocutaneous branches so can be conducted with upper limb orthopedic surgery in hand, rest and elbow surgery distal to the cubital fossa . In this study the investigators will investigate (0.19%) and (0.25%) bupivacaine for postoperative motor power recovery and post-operative analgesic efficacy in ultrasound guided axillary brachial plexus block among pediatric patient undergoing below elbow orthopedic surgery.
详细描述
Patients meeting inclusion criteria will be randomly assigned to receive either:
(Group A: n=30)will receive 0.25% bupivacaine plus 1 µg/kg dexmedetomidine . (Group B: n=30) will receive 0.19% bupivacaine plus 1 µg/kg dexmedetomidine. Using computer generated number and concealed using sequentially numbered, sealed opaque envelope technique. There will be no restrictions or stratifications in the randomization process. The allocation envelope will be opened by the assistant lecturer at the time of anesthetic preparation.
All children will be anaesthetized in accordance with the local policy of the Abu El-Reesh pediatric hospital-Cairo university's pediatric anaesthetic unit. Except for oral clear liquids intake 2 hours before surgery, all children will fast for 6 hours. Patients will attend in the preparation room one hour before the operation to get a preoperative checkup, as well as their age and body weight will be recorded. Premedicated by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg . On arriving the operating room, heart rate (HR) ,oxygen saturation and non-invasive blood pressure will be continuously recorded, using standard monitor (Dräger infinity vista XL).
All patients will be induced with inhalational anesthetic using (100%) O2 + Sevoflurane. After deepening of the anesthesia, I.V. line will be inserted and atracurium 0.5mg/kg and fentanyl 1μg/kg patients will be given, then the patients will be intubated by appropriate size of endotracheal tube volume control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia will be maintained with an isoflurane 1 MAC with 50% oxygen in air, with the goal of keeping the bispectral index (BIS) measurement between (40-60), and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.
Axillary brachial plexus block will be conducted with the patient in supine position under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinded
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of Anesthesiologists (ASA )class I-II
- •Duration of surgery less than 1 hour.
排除标准
- •Parent refusal.
- •Prolonged procedure exceeding 1 hour.
- •Patients with apparent infection at site of needle insertion.
- •Patients with any coagulation disorder(Platelets ≤ 50,000 and/or international normalized ratio INR> 1.5)
- •Patients with known neuropathy or brachial plexus injury.
- •Patients with any cardiac, hepatic, renal failure.
- •Patient with known sensitivity to local anesthetic drugs.
结局指标
主要结局
Motor power using modified bromage scale on admission to the PACU (post anesthesia care unit)
时间窗: on admission to the PACU (10 minutes after extubation)
Modified Bromage scale is a scale designed to assess degree of motor power as shown; Grade Definition 4 Full muscle strength in relevant muscle groups 3 Reduced strength, but able to move against resistance 2 Ability to move against gravity, but not against resistance 1 Discrete movements (trembling) of muscle groups 0 Lack of movement
次要结局
- intraoperative heart rate(every 15 minutes intraoperative till end of surgery (up to 1 hours))
- Pain score at 0,1,2, 4, 8 and 12 hours postoperative.(12 hours)
- cumulative 24 hours opioid consumption(24 hours)
- intraoperative mean blood pressure(every 15 minutes intraoperatively till end of surgery (up to 1 hour))
研究者
Abd elmoneim Adel Abd elmoneim
clinical professor
Cairo University