Exparel Pericapsular Injection: A Prospective Evaluation of Postoperative Pain in Bunion Surgery, First Metatarsophalangeal Joint Fusion, and Cheilectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- OhioHealth
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Opioid Use as Measured by Questionnaire
研究概览
简要总结
Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).
详细描述
The investigators propose a prospective, randomized, single-blinded study of patients who are electing to undergo an outpatient first metatarsophalangeal (MTP) joint procedure (bunionectomy, 1st MTP fusion, or cheilectomy). As a standard, patients undergoing these procedures are given regional anesthesia (adductor canal block plus popliteal block). Patients are then given prescriptions for oral opioids to manage post-operative pain. The purpose of this study is to determine whether a single intrapopliteal administration of Exparel, in conjunction with the standard of care regional block, improves pain relief and therefore decreases use of post-operative opioids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy
排除标准
- •Age less than 18
- •Unable to read/write English
- •Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
- •Weight <70 kg
- •Allergy to local anesthetics
- •History of long-acting opioid use or opioid tolerance (any patient receiving at least 30 mg of oxycodone or equivalent per day (e.g., 6 tabs of Percocet 5/325 mg) regularly for approximately 7 days or more OR who require increased analgesic doses for a period long enough to develop tolerance to the effects of the opioid including analgesia and sedation)
- •Any history of opioid misuse, illicit or prescription
- •Prior MTP joint correction on the surgical limb
- •Midfoot and hindfoot procedures performed concurrently, on the same day
- •Pregnant or breastfeeding
研究组 & 干预措施
Regional Block
Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
干预措施: 0.5% ropivacaine (Drug)
Regional Block Plus Exparel
Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
干预措施: 0.5% ropivacaine (Drug)
Regional Block Plus Exparel
Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
干预措施: Exparel (Drug)
结局指标
主要结局
Opioid Use as Measured by Questionnaire
时间窗: Daily through the third day (72 hours) post-surgery
Compare time to first opioid use over 72 hours between groups
Total Opioid Use as Measured by Questionnaire
时间窗: Daily through the third day (72 hours) post-surgery
Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.
次要结局
- Pain Relief Measured by Defense and Veterans Pain Scale(Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery))