Magnesium as an Adjuvant Agent for Postoperative Pain Control Following Periacetabular Osteotomy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in pain as measured by the Visual Analog Scale (VAS)
研究概览
简要总结
Participants are being asked to participate in this research study because they have elected to undergo periacetabular osteotomy (PAO). This research study is looking at if using IV magnesium during surgery can help to reduce pain after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing periacetabular osteotomy with or without adjuvant hip arthroscopy
排除标准
- •illiterate or non-English speaking patients
- •patients with 2nd or 3rd degree AV block
- •patients with severe renal insufficiency
- •patients with heart failure
- •patients with bradycardia
研究组 & 干预措施
Control group
Participants in this group will receive standard-of-care procedures intraoperatively and post-operatively for pain control.
IV Magnesium Sulfate adjuvant group
Participants in this group will receive standard-of-care procedures intraoperatively and postoperatively along with IV magnesium sulfate for pain control.
干预措施: IV Magnesium Sulfate (Drug)
结局指标
主要结局
Change in pain as measured by the Visual Analog Scale (VAS)
时间窗: Over the first 7 days post operatively, measured every 6 hours
The VAS is a scale from 0-10 with 0 being no pain and 10 being the worst pain ever
Change in number of narcotic medications consumed as measured by the medical record review
时间窗: Over the first 7 days post operatively, gathered every 6 hours.
次要结局
- Change in PROMIS scores(2 weeks, 6 weeks, 3 months, 6 months, 1 year)
- Change in modified Harris Hip Scores (mHHS)(2 weeks, 6 weeks, 3 months, 6 months, 1 year)
研究者
Robert Wetzel, MD
Orthopedic Trauma Surgeon
University Hospitals Cleveland Medical Center