Does a ThoracoLumbar Interfacial Plane (TLIP) Block With Liposomal Bupivacaine Provide Extended Post-operative Analgesia Following Spinal Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction in postoperative pain
研究概览
简要总结
The investigators are looking to recruit patients into a study demonstrating the effectiveness of a superficial nerve block involving the thoracolumbar interfascial plane (TLIP) in reducing postoperative pain in those undergoing spinal surgery
详细描述
Patients undergoing spine surgery with or without fusion experience a great deal of pain especially in the first 3 days after surgery. Spine surgeons are looking for ways to reduce the pain that you experience. Anesthesiologists have introduced a procedure, called a "TLIP block" to provide pain relief. The block involves injecting local anesthetic (numbing pain medication) in the lower back around the site of the surgery. This block has been used by other surgeons for other types of surgeries in the past and has been shown to work.
To determine how effective the block is, the investigators are conducting this investigational study where pain severity in patients who receive one of 2 kinds of local anesthetic or placebo are compared
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients undergoing multilevel lumbar spine surgery, age 18-75
排除标准
- •Opioid use disorder, previous spine surgery, non english-speaking patients, patients with anticipated communication disorders, patients with coagulopathy, prisoners, children, pregnant women, single level hemilaminectomy with or without discectomy
研究组 & 干预措施
Liposomal Bupivicaine
Administration of a combination of lioposomal bupivicane 20ml/266mg mixed with 20mL of 0.375% bupivicaine
干预措施: Liposomal bupivacaine (Drug)
Bupivicane
Administration of 40 ml of 0.375% Bupivicaine with epinephrine 1:400,000
干预措施: Bupivacaine Injection (Drug)
Placebo
Saline injection with 40mL preservative-free saline
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in postoperative pain
时间窗: 24-48 hours
Using Visual Analog Scales on a scale of 0-10, where 0 is no pain and 10 is the worst pain
Total postoperative opioid requirements
时间窗: 1-5 days
Using daily MME
次要结局
- Length of Hospital Stay(1-5 days)
- Time to Ambulation(1-5 days)