A Randomized, Double-Blind, Placebo-Controlled Trial Comparing 48-Hour Post-Operative Administration of Oral Versus Intravenous Acetaminophen in Patients Undergoing Lumbar Spine Fusion Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS) Pain Intensity Scale Score
研究概览
简要总结
The goal of this study is to compare whether oral or intravenous acetaminophen works better for pain control in patients undergoing lumbar spine fusion 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plan for open lumbar laminectomy and fusion surgery (1-3 levels)
- •Able to provide written informed consent
- •Must be able to swallow pills
排除标准
- •Medical contraindications to acetaminophen
- •Emergency surgery
- •Chronic pain unrelated to surgery
- •Pregnancy
研究组 & 干预措施
Oral Acetaminophen 1000mg
Participants take oral acetaminophen and placebo infusion for 48 hours within 2 hours after their spine surgery
干预措施: Acetaminophen Oral Tablet (Drug)
Oral Acetaminophen 1000mg
Participants take oral acetaminophen and placebo infusion for 48 hours within 2 hours after their spine surgery
干预措施: Placebo infusion (Drug)
Intravenous Acetaminophen 1000mg
Participants take acetaminophen infusion and oral placebo for 48 hours within 2 hours after their spine surgery
干预措施: placebo oral tablet (Drug)
Intravenous Acetaminophen 1000mg
Participants take acetaminophen infusion and oral placebo for 48 hours within 2 hours after their spine surgery
干预措施: Acetaminophen infusion (Drug)
结局指标
主要结局
Numerical Rating Scale (NRS) Pain Intensity Scale Score
时间窗: postoperative time intervals: 2 hours (baseline), 6 hours, 12 hours, 24 hours, 36 hours, 48 hours
Mean pain intensity scores post-operatively using 11-point Numerical Rating Scale (NRS) (scale ranges from 0 to 10, and higher score means higher pain)
次要结局
- Length of Hospital Stay(After surgery until discharge, up to 10 days)
- Time to first ambulation after surgery(After surgery until discharge, up to 10 days)
- Quality of Life (EuroQol Questionaire) scale score(48 hours, up to 1 month after surgery)
- Cumulative opioid consumption(After surgery until discharge, up to 10 days)
- Healthcare cost during admission(After surgery until discharge, up to 10 days)
- Number of participants with treatment-related hepatic toxicity(postoperative time intervals: 2 hours(baseline), 24 hours, 48 hours)
- Number of participants with treatment-related skin rash(After surgery until discharge, up to 10 days, whichever is first)
- Change in Patient Global Assessment Scale Score(postoperative time intervals: 2 hours, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours)
- Time to first additional opioid medication dose(After surgery until discharge, up to 10 days)
- Total number of additional opioid medication doses(After surgery until discharge, up to 10 days)
研究者
Atman Desai
Professor of Neurosurgery
Stanford University