A Phase IV Randomized, Single-Blind Trial of Liposomal Bupivacaine (Exparel®) for Pain Control in Costal Cartilage Harvest
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain Scores
研究概览
简要总结
The purpose of this study is to find out whether injecting the U.S. Food and Drug Administration (FDA) approved drug EXPAREL®, a long acting (approximately 96 hours) numbing medication, will reduce pain after rib cartilage removal in comparison to the standard injection of XYLOCAINE®.
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
- 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
- 是
入选标准
- •Diagnosis of functional nasal obstruction or aesthetic nasal concern requiring nasal surgery with costal cartilage harvest.
- •Willing and able to understand and provide written informed consent.
排除标准
- •Known pregnancy.
- •Women who are currently nursing a child.
- •History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder.
- •Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation.
- •Inability to provide informed consent (patients under guardianship).
- •Known hypersensitivity to local anesthetics
- •History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.
- •History of complex pulmonary disease; such as uncontrolled asthma, COPD, or interstitial lung disease as determined by history or review of the medical record.
- •Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate < 60 mL/min/BSA as determined by history or review of the medical record.
- •- History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record.
研究组 & 干预措施
Exparel® Injection Group
On the day of clinically indicated nasal surgery the surgical wound on the chest, where the rib cartilage is removed, will be injected with Exparel®
干预措施: Exparel (Drug)
Xylocaine® Injection Group
On the day of clinically indicated nasal surgery the surgical wound on the chest, where the rib cartilage is removed, will be injected with Xylocaine® as part of standard of care.
干预措施: Xylocaine (Drug)
结局指标
主要结局
Pain Scores
时间窗: 7-10 days following the last administration of study treatment
Measured using a visual analog scale 0=no pain and 10=worst possible
Change in oral pain medication
时间窗: 7-10 days following the last administration of study treatment
Total oral pain medication usage self-reported in pain medication diary
次要结局
- Adverse Reactions(7-10 days following the last administration of study treatment)
研究者
Michael D. Olson, M.D.
Principal Investigator
Mayo Clinic