Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Postoperative Pain #2
研究概览
简要总结
Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL) reconstruction.
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
- 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
- •Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons
- •Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral extra-articular tenodesis
- •Age 18 and older
- •English speaking
- •Ability to complete surveys by phone or in person
- •Ability to provide informed consent
排除标准
- •Revision cases
- •Multi-ligamentous knee injuries
- •Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol
- •ACL reconstruction utilizing non-bone-patellar tendon-bone autografts
- •Allergies to study medications
- •Non-English speakers
- •Known alcohol or narcotic abuse history
- •Existing contract with a pain specialist due to underlying preoperative pain syndrome
- •Preoperative opioid use within the 3 months prior to surgery
研究组 & 干预措施
Group 1: ACL repair + Exparel + nerve block
30 mL Liposomal bupivacaine (Exparel) + 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal and iPACK block (35 mL total)
干预措施: Exparel 30 mL (Drug)
Group 1: ACL repair + Exparel + nerve block
30 mL Liposomal bupivacaine (Exparel) + 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal and iPACK block (35 mL total)
干预措施: 0.5% bupivacaine (Drug)
Group 1: ACL repair + Exparel + nerve block
30 mL Liposomal bupivacaine (Exparel) + 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal and iPACK block (35 mL total)
干预措施: iPACK block (Drug)
Group 2: ACL repair + Exparel + Dexamethasone + nerve block
30 mL Liposomal bupivacaine (Exparel) + 10 mg preservative free Dexamethasone + 5 cc's of 0.5% bupivacaine evenly distributed for both adductor canal and iPACK block (35 mL total)
干预措施: Exparel 30 mL (Drug)
Group 2: ACL repair + Exparel + Dexamethasone + nerve block
30 mL Liposomal bupivacaine (Exparel) + 10 mg preservative free Dexamethasone + 5 cc's of 0.5% bupivacaine evenly distributed for both adductor canal and iPACK block (35 mL total)
干预措施: 0.5% bupivacaine (Drug)
Group 2: ACL repair + Exparel + Dexamethasone + nerve block
30 mL Liposomal bupivacaine (Exparel) + 10 mg preservative free Dexamethasone + 5 cc's of 0.5% bupivacaine evenly distributed for both adductor canal and iPACK block (35 mL total)
干预措施: Dexamethasone (Drug)
Group 2: ACL repair + Exparel + Dexamethasone + nerve block
30 mL Liposomal bupivacaine (Exparel) + 10 mg preservative free Dexamethasone + 5 cc's of 0.5% bupivacaine evenly distributed for both adductor canal and iPACK block (35 mL total)
干预措施: iPACK block (Drug)
结局指标
主要结局
Postoperative Pain #2
时间窗: 14 days
Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain
Postoperative Pain
时间窗: 14 days
Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain
Postoperative opioid use
时间窗: 14 days
assessed using a participant daily diary of how much medication was taken daily for pain
次要结局
未报告次要终点