Evaluation of the Addition of Liposomal Bupivacaine to the Erector Spinae Plane (ESP) Block to Multilevel Lumbar Spinal Fusion Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Postoperative Opioid Consumption During First 72 Hours
研究概览
简要总结
This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery. Given previous studies found long term benefits from liposomal bupivacaine, the hypothesis is that patients will have decreased opioid usage and improved pain scores when compared to a standard ESP block with plain 0.25% bupivacaine.
详细描述
This will be a double blind prospective randomized control trial comparing liposomal bupivacaine with plain bupivacaine in their effectiveness in ESP blocks in lumbar spinal fusion surgery. Patients scheduled for a lumbar spinal fusion procedure will be identified at the time of the scheduled surgery. The endpoints of this study include:
The primary objective is to compare the amount of postoperative intravenous opioid consumption among two study groups for the first 72 hours: Patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with liposomal bupivacaine + 0.25% bupivacaine and patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with 0.25% bupivacaine
The secondary objectives include:
Compare the severity of pain at rest at specific timepoints postoperatively. Compare general quality of recovery via QoR-15 at 48 hours, 72 hours and then at routine follow up visits occurring 2 weeks, 6 weeks, and 12 weeks postoperatively.
Measure rate of postoperative nausea/vomiting in PACU. Measure time to ambulation. Compare analgesia satisfaction score at time of discharge. Measure hospital length of stay.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Liposomal Bupivacaine and Bupivacaine
liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
干预措施: Bupivacaine (Drug)
Bupivacaine only
bupivacaine 0.25% in ESP blocks
干预措施: Bupivacaine (Drug)
Liposomal Bupivacaine and Bupivacaine
liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Postoperative Opioid Consumption During First 72 Hours
时间窗: 12 hours, 24 hours, 48 hours, 72 hours
The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours
次要结局
- Time to Ambulation(average 26-27 hours)
- Change in Pain Score(up to 12 weeks)
- Quality of Recovery (QOR 15)(72 hours)
- Number of Participants With Postoperative Nausea/Vomiting (PONV)(in PACU (4 hours))
- Hospital Length of Stay(average 72 hours)
研究者
Christina Jeng
MD, Associate Professor
Icahn School of Medicine at Mount Sinai