A Randomized Controlled Trial of the Effect of Liposomal Bupivacaine (Exparel) When Compared to Saline Control in Reducing Opioid Utilization for Pain Management in Postoperative Lumbar Spine Surgeries.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Postoperative Opioid Utilization
研究概览
简要总结
The purpose of this study is to establish a relationship between liposomal bupivacaine surgical site injection and postop opioid utilization.
详细描述
Multiple studies have shown that people who are taking opioids for acute pain have a greater likelihood of long-term opioid use. Many efforts have been made to reduce postop pain and opioid use, including developments in incisional site injections of local anesthetics, continuous incisional site anesthetic pain pumps, as well as multimodal comprehensive pain management, yet patients undergoing lumbar spine surgeries continue to depend on opioids for relief. Liposomal bupivacaine (LB) (Exparel) is a novel formulation of long-acting bupivacaine, lasting for up to 72 hours following injection. LB has been shown to be efficacious in reducing postop pain and opioid utilization in several different surgical settings, however its utility in spine surgeries has still yet to be established. The goal of this study is to determine the efficacy of liposomal bupivacaine vs saline in lumbar spine surgeries in reducing opioid utilization as well as determine if there difference patient reported outcomes and length of hospital 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)
盲法说明
Liposomal bupivacaine can be differentiated visually from normal saline. In order to blind the surgeons from treatment vs control, the syringes containing the medication or saline will be sheathed by the investigational drug study department.
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
- •Patients undergoing isolated lumbar spine procedures using a posterior approach.
- •Surgical spine procedures include:
- •Single-level lumbar spine surgeries with or without fusion
- •Multi-level lumbar spine surgeries with or without fusion
排除标准
- •Procedures involving intrathecal space
- •Patients with documented allergy to local anesthetics (bupivacaine, lidocaine, procaine, benzocaine).
- •Acute lumbar trauma that requires immediate spine stabilization
- •Revision of failed back surgeries (including nonunion and malunion)
- •Revision of wound or hardware
- •Contraindication to regional anesthesia
- •Patients with chronic use of opioid medications
- •Liver dysfunction (INR > 1.5, albumin <2.8g/dl, bilirubin >2mg/dl)
- •Renal dysfunction (eGFR < 60ml/min/1.73m2)
- •Severe chronic obstructive pulmonary disease requiring continuous oxygen supplementation
- •Unable to give informed consent
- •Pregnancy
研究组 & 干预措施
Placebo Group
Patients in this group will be given the placebo (sterile saline).
干预措施: saline 0.9% (Drug)
Liposomal bupivacaine
Patients in this group will be given the study drug (liposomal bupivacaine).
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Postoperative Opioid Utilization
时间窗: Until final follow-up, up to 8 weeks.
Comparing post operative opioid usage reduction between treatment and placebo group.
次要结局
- Operative Data and Complications(Until final follow-up, up to 8 weeks.)
- Post Operative Pain Scores(Until final follow-up or up to 8 weeks after surgery date, whichever comes first.)
- Length of Stay(Until final follow-up, up to 8 weeks.)