NCT03514277终止4 期
Combined Administration of Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Analgesia in Posterior Lumbar Spine Surgery - A Prospective Randomized Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Mean Postoperative Pain Score
研究概览
简要总结
The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of surgery, compared to the patients that doctors use only EXPAREL® or bupivacaine to manage their pain. This information will help doctors determine which approach works best for patients who will receive surgery in their lumbar spine in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older;
- •Primary indication is low back pain, lumbosacral radiculopathy, lumbar disc degeneration, lumbar disc herniation, stenosis, spondylolisthesis, spondylolysis, or deformity requiring surgical intervention;
- •Scheduled to undergo primary, 1 or 2 level, posterior lumbar laminectomy with or without fusion, discectomy with fusion, or fusion at Virtua Memorial Hospital;
- •Willing to provide informed consent, participate in study, and comply with study protocol.
排除标准
- •Hypersensitivity or allergy to local anesthetics;
- •Pregnant or contemplating pregnancy prior to surgery;
- •Previous surgery in lumbar spine (i.e. other than microdiscectomy);
- •Prior treatment for alcohol, recreational drug, or opioid abuse;
- •Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
- •Surgery involving more than 2 vertebral levels;
- •Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests [21]; could also run into potential issues with reimbursement).
- •Lactating women
- •Patients with end stage liver disease
研究组 & 干预措施
Local infiltration of EXPAREL and Bupivacaine
Active Comparator
干预措施: Exparel (Drug)
Local infiltration of EXPAREL and Bupivacaine
Active Comparator
干预措施: Bupivacaine (Drug)
Local infiltration of Exparel
Active Comparator
干预措施: Exparel (Drug)
Local infiltration of Bupivacaine
Active Comparator
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Mean Postoperative Pain Score
时间窗: last day of hospitalization, average of 3 days in hospital
Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain
次要结局
- Mean Time to Achieve Physical Therapy Discharge(last day of hospitalization, average of 3 days in hospital)
- Total Consumption of Opioids During Hospital Stay(last day of hospitalization, average of 3 days in hospital)
- Number of Participants With Opioid Related Adverse Events(last day of hospitalization, average of 3 days in hospital)
研究者
研究点 (1)
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