A Comparison of Epidural Analgesia With Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Post-operative Pain as Assessed by Visual Analogue Scale (VAS)
研究概览
简要总结
- Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
- Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia.
Hypothesis:
The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with epidural catheter placement will have superior post-operative analgesia compared to patients undergoing standard care.
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
- None
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
- •Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion surgery
排除标准
- •Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
- •Inability to follow directions or comprehend the English language.
- •Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.
- •Prisoners.
- •Patient refusal to provide informed consent.
- •Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine).
研究组 & 干预措施
Intravenous opioids
This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
干预措施: Dilaudid (Drug)
Epidural Catheter
The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.
干预措施: Epidural Catheter - Dilaudid (Other)
结局指标
主要结局
Post-operative Pain as Assessed by Visual Analogue Scale (VAS)
时间窗: Postoperative day 1
The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
次要结局
- Number of Participants Readmitted to Hospital Within 30 Days of Surgery(Post-operative Day 30)
- Wound Infection Rates(during hospitalization (approximately 3-8 days))
- Patient Satisfaction With Perioperative Analgesia(6-Week Follow up Visit)
- Patient Satisfaction With Overall Care(6-Week Follow up Visit)
- Number of Participants With Events of Special Interest(Post-operative Day 30)
- Length of Hospital Stay(during hospitalization (approximately 3-8 days))
- Number of Participants Experiencing Delirium(Post-operative Day 3)
- Number of Participants With Adverse Events Related to the Study(6-week Follow up Visit)
- Total Post-operative Opioid Consumption(during hospitalization (approximately 3-8 days))