Randomized Controlled Trial Assessing the Effect of Intraoperative Dexamethasone in the Management of Postoperative Analgesia and Stiffness After Distal Radius Fixation
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
- Patient rated wrist evaluation
研究概览
简要总结
The study is designed to assess the use of intraoperative dexamethasone on postoperative analgesia and stiffness after open reduction and internal fixation of distal radius fractures. The idea is that the dexamethasone will aid in reducing postoperative swelling which will then improve pain control as well as overall function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Willingness to comply with study procedures and
- •Male or female greater than 18 years old
- •American Society of Anesthesia class I/II/III
- •Ability to take oral medicine in order to assess opioid regimen postop
- •Distal radius open reduction and internal fixation surgery with single incision and volar plate
- •Ability to consent for and receive a preoperative upper extremity nerve block by anesthesia
排除标准
- •Chronic opioid users
- •Prescriptions for selective-serotonin reuptake inhibitors, gabapentin, duloxetine within 3 days of surgery
- •History of diabetes and A1C > 8
- •Systemic glucocorticoids within 1 month of study enrollment
- •Inability to take ibuprofen or acetaminophen due to allergy or condition
- •History of hepatitis
- •Pregnancy or lactation
- •Allergic to opioids
- •Known allergic reactions to components of IV dexamethasone
研究组 & 干预措施
Dexamethasone
Patient will receive intraoperative dexamethasone during distal radius open reduction and internal fixation
干预措施: Dexamethasone (Drug)
No dexamethasone
Patient will not receive intraoperative dexamethasone during distal radius open reduction and internal fixation
干预措施: No dexamethasone (Other)
结局指标
主要结局
Patient rated wrist evaluation
时间窗: 48 hours, 1 week, 2 weeks
15-item questionnaire designed to measure wrist pain and disability in activities of daily living. PWRE will be assessed at multiple time point to assess for change in the score. The higher the score, the more function exhibited.
次要结局
- Total opioid consumption(48 hours, 1 week, 2 weeks)
- Finger-to-palm distance(48 hours, 1 week, 2 weeks)
- Visual analog scale(48 hours, 1 week, 2 weeks)