Effectiveness of intermitent dry brachial plexus stimulation versus intermittent local anesthetic infusion of postoperative pain relief in patients undergoing shoulder surgery.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Local anesthetic consumption (0.2% ropivacaine) in 24 hours in both groups
研究概览
简要总结
Shoulder surgery frequently results in pain that is often difficult to manage with current analgesic options. Inadequate analgesia after shoulder surgery may lead to decreased range of motion, delay recovery, increase morbidity and lead to patient dissatisfaction. Moreover, a persistent acute pain may lead to chronic pain and narcotic dependence.
The most probable model involves “gate control†theory in which large-diameter afferent nerve fibers are stimulated, inhibiting the transfer of pain signals from small-diameter afferent fibers to the central nervous system at the level of the spinal cord.
In recent years, the dry catheter technique of stimulating the brachial plexus without any drug delivery has been described in shoulder arthroplasty and has documented effective pain relief. However, there is a lack of trials comparing this technique with local anaesthetic infusion for postoperative pain in shoulder arthroplasty patients.
We hypothesised was that stimulation of brachial plexus in postoperative period may reduce the need of local anesthetic (LA) infusion and overall LA consumption.
Therefore, we planned this study to understand the postoperative block efficacy by stimulation of interscalene brachial plexus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA-1 and undergoing shoulder surgery.
排除标准
- •The patients with chronic opioid use (more than 4 weeks), neuromuscular deficit within the operative extremity, implanted spinal cord stimulator, cardiac pacemaker/defibrillator deep brain stimulator, or other implantable neurostimulator.
- •The patients with chronic opioid use (more than 4 weeks), neuromuscular deficit within the operative extremity, implanted spinal cord stimulator, cardiac pacemaker/defibrillator
- •history of bleeding disorder; antiplatelet or anticoagulation therapies other than aspirin; allergy to local anesthetics will be excluded.
结局指标
主要结局
1. Local anesthetic consumption (0.2% ropivacaine) in 24 hours in both groups
时间窗: Baseline and after 24 hrs postoperatively.
次要结局
- 1. Pain scores as assessed by NRS in the postoperative period(2. NRS following stimulation in the dry stimulation group)
研究者
Dr Sandeep Diwan
Sancheti Institute of Orthopedics and Rehabiliation