A Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Axillary Blocks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Motor block duration
研究概览
简要总结
Dexamethasone prolong the duration of brachial plexus blocks, but the optimal route, intravenous (IV) or perineural (PN), remains controversial.
This Multi-centric trial compare IV and PN dexamethasone for ultrasound-guided axillary brachial plexus blocks (AXBs). Research hypothesis is that PN modality will outlast its IV counterpart. Since analgesic duration and sensory duration can be influenced by intake of pain medications and surgical trauma to small cutaneous nerves, the investigators will select motor block duration as the main outcome.
详细描述
After Ethics Committee of the McGill University Health Centre, a total of 150 patients undergoing upper extremity surgery (below the elbow) will be recruited.
All AXBs will be supervised by one of the coauthors and conducted preoperatively in an induction room. This area will have full access to an oxygen source, resuscitative equipment and drugs.
All patients will have fasted for at least eight hours. An IV cannula will be placed prior the block and will be monitored and given oxygen at 2-4 L/min through nasal cannulas.
Light sedation will be provided for patient comfort if needed.Patients will be placed supine with the shoulder abducted and the elbow flexed. The AXB will have a puncture site superior to the axillary artery. After skin disinfection and draping, a skin wheal will be raised with 3 mL of lidocaine 1.5%.
In both groups, 30 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL will be used. A 22-gauge, 5 cm block will be advanced under direct US vision toward the musculocutaneous nerve. Six mL of LA will be deposited in this location. The needle will then be directed posterior to the artery, at 6 o'clock position and twenty-four mL of LA will be deposited to obtain a spread around the artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Below Elbow surgery
- •Age between 18 and 80 years
- •American Society of Anesthesiologists classification 1-3
- •Body mass index between 18 and 35 kg/m2
排除标准
- •Adults who are unable to give their own consent
- •Pre-existing neuropathy (assessed by history and physical examination)
- •Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial prothrombin time ≥ 50)
- •Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- •Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- •Allergy to local anesthetics (LAs)
- •Pregnancy
- •Prior surgery in the axillary region
- •Chronic pain syndromes requiring opioid intake at home
结局指标
主要结局
Motor block duration
时间窗: 24 hours
Duration of the motor block (defined as the temporal interval between the end of LA injection through the block needle and the return of movement to the hand and fingers). Patient is contacted at the next day of the surgery and asked about the time when the motor block started to disappear.
次要结局
- duration of the sensory block(24 hours)
- Analgesia duration(24 hours)
- Onset time(30 minutes)
- Success rate(30-60 minutes)
研究者
De QH Tran
Associate Profesor
Montreal General Hospital