A Double Blinded Randomized Control Trial in Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall length of hospital stay from hospital admission to hospital discharge
研究概览
简要总结
Evaluate the benefit of using liposomal bupivicaine in lumbar laminectomies in terms of length of stay, IV narcotic use, 30-day narcotic use, visual analog score (VAS) and 30-day readmissions
详细描述
Recent evidence suggests the use of liposomal bupivicaine (LB) in lumbar spine surgery shortens length of hospital stay and overall post-operative narcotic use. Studies have shown its utility in single level microdiscectomies and lumbar fusions, but there have been no publications regarding lumbar laminectomies and associated outcomes with LB. The investigators' hypothesis is that LB will significantly shorten inpatient stays as well as overall narcotic usage in single, double or multi-level lumbar laminectomies.
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)
盲法说明
The PI, co-Investigators, and clinicians will be blinded to the patient's treatment arm. The pharmacist will be unblinded.
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
- •Male or Female
- •Adult (≥18 yo)
- •Lumbar stenosis
排除标准
- •Co-morbidities precluding surgery
- •Breastfeeding
- •Need for instrumented fusion
- •Intra-operative CSF leak (identified by gush of CSF)
- •Daily pre-operative opioid use of > 25 morphine Eq/day
- •Previous lumbar surgery at indicated level
研究组 & 干预措施
Liposomal Bupivicaine
Treatment with liposomal bupivicaine
干预措施: Liposomal bupivacaine (Drug)
Standard Local Anesthestic
Treatment with Standard Local Anesthestic
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Overall length of hospital stay from hospital admission to hospital discharge
时间窗: From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.
Length of stay will be measured in hours
次要结局
- IV narcotic usage(From date of hospital admission until date of hospital discharge, assessed up to 2 weeks.)
- Change in Visual Analog Pain scale scores(Screening, Day of Procedure, Prior to Hospital Discharge (Post-op, Up to 2 weeks), Up to 30-days post-surgery (Follow-Up#1) and up to 12-months post-op follow up)
- 30-day readmission rates(Day 30)
- 30-day narcotic usage(30-day post surgery)