Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block Utilizing Continuous Reassessment Method for Arthroscopic Rotator Cuff Shoulder Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Block Success
研究概览
简要总结
Prospective, patient-blinded study utilizing a novel Continuous Reassessment Method that concomitantly considers both block success and block side effects (lung dysfunction) for brachial plexus nerve blocks.
详细描述
Success or failure of the brachial plexus block for any given volume will be determined by the verbal analogue pain scale score obtained 60 minutes after surgical end time. Volumes will be determined by continuous reassessment method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgical candidate for Arthroscopic rotator cuff surgery
- •ASA I-III
排除标准
- •Inability to give informed consent
- •Inability to complete consent process in English
- •allergy to ropivacaine
- •neuropathy
- •contraindications to peripheral nerve block per ASRA guidelines
- •chronic opioid use
- •infection at the injection/catheter site
- •limb restriction due to medical history
- •history of moderate - severe lung disease.
研究组 & 干预措施
Brachial Plexus Block Group 1
Interscalene
干预措施: Dose of 0.5% Ropivacaine (Drug)
Brachial Plexus Group 2
Supraclavicular
干预措施: Dose of 0.5% Ropivacaine (Drug)
Brachial Plexus Group 3
Suprascapular
干预措施: Dose of 0.5% Ropivacaine (Drug)
结局指标
主要结局
Block Success
时间窗: 60 mins after surgery
Block Success measured by opioid (mcg of fentanyl delivered)
Lung Function
时间窗: 60 mins after surgery
Block success as measured by preservation of lung function (Vital Capacity in L)
次要结局
- Vital Capacity(60 minutes after surgery)
- Pulse Oximetry(60 minutes after surgery)
- Side Effects(60 minutes after surgery)
- Diaphragm Excursion(60 minutes after surgery)