Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement in shoulder function as demonstrated by increased range of motion
研究概览
简要总结
In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing shoulder pain and improving range of motion compared to a single-dose interscalene block.
详细描述
Shoulder manipulation under anesthesia to treat idiopathic adhesive capsulitis is performed only when conservative treatment fails to remedy the condition.
It is common practice to use an interscalene nerve block as anesthesia for this surgical intervention. This randomized prospective study is designed to evaluate the effects of two different anesthesia methods on patient's post-surgical rehabilitation after manipulation. Forty patients scheduled for surgery will be entered into this study. Patients will be randomly assigned to receive a single-doseinterscalene block or a single-dose interscalene block and an indwelling nerve catheter which will provide a continuous infusion of local anesthetic. Patients with the continuous infusion of local anesthetic will receive the additional anesthesia for 24 hours. Patient's range of motion will be evaluated pre-op, intra-op and post-operatively at 10 days, 4,8,16 weeks and 6 months
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females over the age of 18 with a diagnosis of idiopathic adhesive capsulitis
- •Failed conservative treatment for a minimum of 4 months
- •Patient had 3 sequential office visits with no clinical improvement
排除标准
- •Adhesive capsulitis following a surgical procedure and/or fracture
结局指标
主要结局
Improvement in shoulder function as demonstrated by increased range of motion
时间窗: 10 days, 4, 8, 16 weeks and 6 months
The primary outcome measure will be an improvement in shoulder function as measured by the ASES shoulder score.
次要结局
- Decrease in shoulder pain(10 days, 4, 8, 16 weeks and 6 months)