Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Prior to Foot and Ankle Procedures: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Amount of pain medication used after surgery
研究概览
简要总结
This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.
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, Investigator)
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
- •Participants with foot and ankle procedures at Jefferson Surgery Center, Navy Yard
- •Participants with foot and ankle orthopedic procedures requiring a preoperative nerve block
- •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 foot and ankle cases
- •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
- •Participants who are pregnant, plan to become pregnant, or are breastfeeding.
研究组 & 干预措施
Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block
Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 10 mL of 0.75% bupivacaine
干预措施: Exparel 266 MG Per 20 ML Injection (Drug)
Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block
Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 10 mL of 0.75% bupivacaine
干预措施: Bupivacaine Hcl 0.75% Inj (Drug)
Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block
Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 1 mL of 10 mg preservative free Dexamethasone + 10 cc's of 0.75% bupivacaine
干预措施: Exparel 266 MG Per 20 ML Injection (Drug)
Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block
Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 1 mL of 10 mg preservative free Dexamethasone + 10 cc's of 0.75% bupivacaine
干预措施: Bupivacaine Hcl 0.75% Inj (Drug)
Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block
Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 1 mL of 10 mg preservative free Dexamethasone + 10 cc's of 0.75% bupivacaine
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Amount of pain medication used after surgery
时间窗: 14 days
Collected as tablets taken since all participants will be prescribed oxycodone
Pain level after surgery
时间窗: 14 days
Participants will be asked daily what their pain levels are using the Visual Analog (VAS) pain scale
次要结局
未报告次要终点