Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change in forced vital capacity (FVC)
研究概览
简要总结
One of the most frequently performed peripheral nerve blocks (the injection of local anesthetic near nerves to block sensation/ movement to a specific part of the body) is the interscalene brachial plexus block for upper extremity surgeries. This type of block can unmask underlying respiratory issues such as shortness of breath due to a well-known and typically insignificant side effect of temporary diaphragmatic paralysis.
The nerve block may be able to use saline solution to wash out the local anesthetic and potentially reverse this respiratory side effect. Specifically, the goal of this study is to determine if the injection of saline through the nerve block catheter reverses blockade of the phrenic nerve supplying the diaphragm, without affecting the ability of the nerve block to provide pain control after surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (18 years and over) scheduled for surgery requiring a continuous interscalene brachial plexus nerve block catheter as part of their anesthetic care.
排除标准
- •Concomitant life-threatening injuries and other concomitant injuries causing significant pain
- •Any condition impairing patient's ability to consent to participation in study, and an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder, infection in the vicinity of the block, and patient refusal.
研究组 & 干预措施
Placebo group
After surgery, in the post-operative recovery room, patients randomized to both the intervention and control groups will have 10cc 0.5% ropivacaine bolused via their nerve catheters. After 30 minutes, the following will be measured/assessed: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. This control group will have no normal saline injected into their nerve catheter (no intervention). Then, both the control and treatment groups will have the following measured/assessed after 5, 15 and 30 minutes: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group.
干预措施: Placebo (Other)
Treatment group
After surgery, in the post-operative recovery room, patients randomized to both the intervention and control groups will have 10cc 0.5% ropivacaine bolused via their nerve catheters. After 30 minutes, the following will be measured/assessed: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. This group will then have 30ml of normal saline injected into their nerve catheter. Then, both the control and treatment groups will have the following measured/assessed after 5, 15 and 30 minutes: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group.
干预措施: Normal saline injected via interscalene nerve catheter (Procedure)
结局指标
主要结局
Change in forced vital capacity (FVC)
时间窗: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)
Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
Change in peak expiratory flow (PEF)
时间窗: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)
Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
Change in forced expiratory volume in 1 second (FEV1)
时间窗: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)
Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
次要结局
- Brachial plexus sensory and motor exam(Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (2 minutes each for a total of 3 assessments).)
- Pain scores(Pain scores will be assessed before nerve block is placed, within 1 hour after the surgery, while receiving either the placebo or treatment. (1 minute each for a total of 3 assessments))
- Diaphragmatic excursion(Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (5 minutes each for a total of 3 assessments.))
研究者
Chi-Ho Ban Tsui
Professor
Stanford University