Determining the Minimal Effective Volume (MEAV95) for Interscalene Brachial Plexus Block for Surgical Anesthesia
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- MEAV95 of ropivacaine 0.75%
研究概览
简要总结
Interscalene block (ISB) consistently demonstrates superior pain relief after shoulder surgery. However, patients can experience complications such as blurred vision, hoarseness and shortness of breath with the standard volumes of local anesthetic used in contemporary practice. Patients with respiratory diseases are precluded because of the potential effects on respiration. However, they are then exposed to the risks of general anesthesia and opioid medications which can also have detrimental effects on respiration. Ultrasound guided ISB can reduce the local anesthetic volume required to produce anesthesia for shoulder surgery; this may reduce the complications from ISB to allow patients previously unable to benefit to have this technique, such as patients with obesity and respiratory disease. In order to do so the investigators will use an up-down methodology to find the minimum volume of local anesthetic to provide sufficient anesthesia for shoulder surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective arthroscopic shoulder surgery in the sitting position
- •Patients aged >=18 and <=75 years
- •ASA I-III
排除标准
- •Patient refusal for surgery under ISBPB with sedation
- •Lack of capacity to provide informed consent
- •Pre-existing COPD, unstable asthma or diaphragmatic dysfunction
- •Coagulopathy
- •Infection at injection site
- •Allergy to local anesthetics
- •Opioid tolerance (>30mg oral morphine or equivalent/day for >1 week)
- •Inability to complete questionnaires and assessments (consent, follow-up phone call) due to language barrier
- •Pregnancy or lactation
结局指标
主要结局
MEAV95 of ropivacaine 0.75%
时间窗: 30 minutes post injection
to determine the MEAV95 of ropivacaine 0.75% at the level of root C5-6 using the dose-finding protocol. The success of surgical anesthesia is defined by the presence of sensory blockade (no sensation/score of 0 to pinprick testing) 30 minutes post injection of local anesthetic
次要结局
- Motor blockade(30 minutes)
- Bedside spirometry(30 minutes post block, 30min post-surgery, and 2 hours post surgery)
- Diaphragmatic excursion(30 minutes post block, and 2 hours post surgery)
- Complications(30 minutes)
- Pain Scores on Visual Analog Scale(at baseline, after surgery at 30 and 60 minutes in the PACU, and at 1 hour intervals until discharge)
- Total opioid consumption until discharge(24 hours (at discharge))
- Opioid related side effects(24 hours (at discharge))
- Time to first analgesic use(within 24 hours post surgery)
研究者
Dr. Colin McCartney
Staff Anesthesiologist and Director of Research
Sunnybrook Health Sciences Centre