Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Reduction in opioid consumption in the first 48 hours post-operatively
研究概览
简要总结
Minimally invasive (MIS) lumbar decompression and fusion is a new procedure that aims to reduce post-operative pain, opioid consumption and related side effects, and length of hospital stay. Current research demonstrates a modest improvement in these areas beginning on the third post-operative day. MIS fusion, however, incurs significant cost as the average time of the procedure is approximately one third greater (from 148 minutes to 191 on average). Epidural analgesia has clearly demonstrated benefits for conventional open laminectomy. In order to fully maximize the benefits of an MIS technique, early post-operative analgesia/pain must be improved. The aim of this study is to combine two techniques to ultimately improve patient outcomes and satisfaction. This will be a randomized trial involving 32 patients undergoing MIS decompression and fusion with half the study group receiving active epidural and IV-PCA and the other half receiving epidural placebo and IV-PCA.
The hypothesis is that epidural analgesia will reduce post-operative opioid consumption, improve pain scores, and decrease time to ambulation as well as discharge from hospital after MIS decompression and fusion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled to undergo minimally invasive lumbar decompression and fusion at the Toronto Western Hospital
- •both genders
- •ASA I to III
- •BMI less than 35
排除标准
- •refuses treatment randomization
- •inability to give informed consent
- •language barrier
- •local anesthetic allergy
- •allergy to shellfish or eggs
- •bleeding diathesis
- •sickle cell disease or trait
- •pregnancy
- •drug addiction
- •psychiatric history
- •severe intercurrent illness (ASA IV or V)
- •patients requiring anesthesia of other surgical sites
研究组 & 干预措施
1
Control group receiving saline placebo through an epidural catheter
干预措施: Saline Placebo (Drug)
2
Experimental group receiving active medication through the epidural catheter
干预措施: Bupivicaine, Hydromorphone (Drug)
结局指标
主要结局
Reduction in opioid consumption in the first 48 hours post-operatively
时间窗: 48 hours
次要结局
- Reduction in VRS pain scores(Duration of Admission)
- Reduction in total opioid consumption(Duration of Admission)
- Reduction in time to discharge(Duration of Admission)
- Reduction in opioid related side effects(Duration of Admission)