Prospective, Randomized, Controlled Trial of an Opiate Sparing Protocol Versus Standard Opiate-Based Protocol Following Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Visual Analog Score (VAS) at Week 2
研究概览
简要总结
To investigate the difference between an opiate sparing pain management protocol versus a standard opiate-based protocol following shoulder arthroplasty in the ninety day postoperative period regarding visual analog scores and oral morphine equivalents.
详细描述
This is a single center, investigator initiated, prospective, randomized, controlled trial conducted among patients who have given voluntary consent to participate. Participation will last until the completion of the twelve weeks standard of care follow up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary shoulder arthroplasty
- •18-85 years of age
- •Body Mass Index greater than or equal to 45
- •Willing and able to provide written informed consent
- •Willing and able to cooperative in the required postoperative therapy
- •Willing and able to complete scheduled follow-up evaluations
- •Fluent in verbal and written English
排除标准
- •Less than 18 years or over 85 years of age
- •Unable to provide written informed consent, cooperate with postoperative therapy, or complete follow-up evaluations
- •Known sensitivity, allergy, or intolerance to medications with protocols
- •Renal disease as defined by active or impending dialysis within six months or kidney transplant
- •Concomitant ipsilateral upper extremity injury or condition other than shoulder that compromises function
- •Chronic pain syndrome
- •Five consecutive days of opiate use with the previous ninety days
- •Worker's compensation claim
- •Women who are pregnant, planning to become to become pregnant, or breastfeeding
结局指标
主要结局
Visual Analog Score (VAS) at Week 2
时间窗: postoperative day fourteen (two weeks)
The Visual Analog Score (VAS) is a a validated patient reported pain score with possible range from zero (no pain) to ten (worst possible pain).
次要结局
- Number of Opioid Pain Pills Taken(Post-operative Day 1 through 12 weeks)
研究者
Tyler J. Brolin
Principal Investigator
Campbell Clinic