Prospective, Randomized, Double-blind, Placebo-Controlled Study to Compare the Effects of Intravenous Versus Oral Acetaminophen on Postoperative Clinical Outcomes After Ambulatory Lumbar Discectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain scores
研究概览
简要总结
Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores when given preoperatively. This study investigates if there is a difference between the intravenous and the oral forms when given preoperatively to patients undergoing lumbar microdiscectomy. We hypothesize that the intravenous formulation does not improve pain scores or decrease opioid consumption during the first postoperative day compared to the oral formulation.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single level lumbar micro disk surgery
- •Ages 18-65
- •Exclusion Criteria
- •morbid obesity
- •prior back surgery
- •opioid tolerance
- •pregnancy
排除标准
- 未提供
研究组 & 干预措施
oral acetaminophen
Patients in this arm of the study will receive oral acetaminophen and an IV placebo
干预措施: oral acetaminophen (Drug)
intravenous acetaminophen
Patients in this arm of the study will receive IV acetaminophen and an oral placebo
干预措施: intravenous acetaminophen (Drug)
结局指标
主要结局
Postoperative pain scores
时间窗: Day of surgery
Pain scores are measured using a visual analog scale with patient at rest and also with movement of the lower extremities at four separate times following surgery.
次要结局
- Quantity of intraoperative and postoperative opioids administered.(Day of surgery)