NCT01355757已完成早期 1 期
Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff 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
- 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
- 是
入选标准
- •Patients who agree to participate in the study will be asked to sign the informed consent and the HIPAA form.
- •Inclusive criteria are:
- •18-75 years of age
- •ASA physical status I-III
- •BMI < 35 kg/m2
排除标准
- •all open shoulder procedures
- •patient having difficulty understanding the instruction on using the anesthetic infusion pump
- •contraindications to administration of regional anesthesia (e.g., allergy to a local anesthetic, local infection and coagulopathy)
- •significant neurologic disorders of the upper extremity
- •psychiatric or cognitive disorders
- •history of substance abuse or chronic opioid use
研究组 & 干预措施
Baxter INFUSOR System
Experimental
Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
干预措施: Single Injection of Local Anesthetic (Drug)
Single Injection of Local Anesthetic
Active Comparator
Single injection of 20 ml ropivacaine 0.5%
干预措施: Baxter INFUSOR System (Device)
结局指标
主要结局
Quality of Life
时间窗: 24 weeks
To describe rehabilitation achievement and quality of life during 24-week follow-up after shoulder arthroscopy and rotator cuff repair, and identify any association between type of anesthesia procedure and patients' quality of life
次要结局
未报告次要终点
研究者
Admir Hadzic
Dr.
St. Luke's-Roosevelt Hospital Center
研究点 (1)
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