Ultrasound Guided Supraclavicular Nerve Block: Comparison Between a Mixture of Mepivacaine and Ropivacaine, and Sequential Injection of Mepivacaine Followed by Ropivacaine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Duration of Analgesia.
研究概览
简要总结
This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics.
详细描述
Patients will be randomized into one of two groups, Group M: Ropivacaine and Mepivacaine - subject will receive two injections before surgery begins. These two injections will consist of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml).
Group S: Mepivacaine followed by Ropivacaine. Subjects will receive two injections before surgery begins. One injection will contain mepivacaine (15 ml) and the other will contain ropivacaine (15 ml).
On the first, second, and third mornings after surgery,subjects will be asked to rate their pain on a scale of 1 to 10. If the subject is discharged from the hospital, a telephone call will be made to the subject's home to collect this information.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing upper extremity procedures suitable for supraclavicular anesthesia, including but not limited to oHand surgery oForearm surgery oElbow surgery
- •Age between 18 and 70 years
排除标准
- •Contraindications to supraclavicular block
- •Coagulopathy
- •Infection at the needle insertion site
- •Severe chronic obstructive pulmonary disease (COPD)
- •Contralateral pneumothorax or diaphragmatic paralysis
- •Pregnancy
- •Preexisting neuropathy involving the surgical limb
- •Routine opioid use
- •Inability to attain adequate ultrasound images in the supraclavicular area
研究组 & 干预措施
Group 1
combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
干预措施: Ropivacaine (Drug)
Group 1
combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;
干预措施: Mepivacaine (Drug)
Group 2
sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
干预措施: Ropivacaine (Drug)
Group 2
sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.
干预措施: Mepivacaine (Drug)
结局指标
主要结局
Duration of Analgesia.
时间窗: During surgery: postoperative day 0
The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.
次要结局
- Time to Complete Motor Block(during surgery from induction time to end case time)
- Time to Onset of First Sensory Block(during surgery)
- Maximum Verbal Response Score (VRS) With Rest(through post operative day 3)
- Maximum Verbal Response Score (VRS) With Movement(through post operative day 3)
- Duration of Analgesia(from surgery date to postoperative day 1)
- Total Opioid Consumption(postoperative day 1 to day 3)