Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Duration of block
研究概览
简要总结
Liposomal Bupivacaine (Exparel) has been recently studied as the active agent utilized in various nerve block. Due to its liposomal form allowing for extended delivery, Exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and decreased opioid use. This study compares the efficacy and effect on opioid use of peripheral nerve blocks and local infiltration with and without Exparel in patients undergoing foot and ankle surgery.
详细描述
three study groups: A - surgeon infiltrates with exparel on site of surgery; B - anesthesia provides a regional nerve block (popliteal/adductor blocks) with plain local anesthetic (bupivacaine); C - anesthesia provides a regional nerve block (popliteal/adductor) with Exparel/bupivacaine mix. Follow up occurs on postop day 4 via phone call to patient. Measured outcomes include opioid consumption in post anesthesia care unit phase (oral morphine equivalents), block duration, number of opioid pills used by postop day 4, oral morphine equivalent consumption by postop day 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
patient is blinded to study
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
- •Adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution
- •English speaking
- •Able to provide consent to surgery and study participation
排除标准
- •Non-elective or emergent foot and ankle surgery
- •Non-english speaking
- •Does not possess medical decision making capacity
研究组 & 干预措施
Peripheral Nerve Block with Exparel
Liposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine
干预措施: Exparel (Drug)
Peripheral Nerve Block Without Exparel
Lower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine
干预措施: Peripheral Nerve Block (Drug)
Local Infiltration of Exparel
Liposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% bupivacaine
干预措施: Exparel (Drug)
结局指标
主要结局
Duration of block
时间窗: 3 Months
Duration of block
时间窗: 1 year
次要结局
- oral morphine equivalent use by postoperative day 4(3 months)
- number of opioid pills used by postoperative day # 4(3 months)
- PROMIS Scores(3 months)
- number of opioid pills used by postoperative day # 4(1 year)
- PROMIS Scores(1 year)
- oral morphine equivalent use by postoperative day 4(1 year)