Evaluation of the Safety and Efficacy of EXPAREL® (Bupivacaine Liposome Injectable Suspension) When Administered Via Infiltration Versus Instillation in Subjects Undergoing Bilateral Augmentation Mammoplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Duration of Analgesia
研究概览
简要总结
This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).
详细描述
Each subject underwent bilateral augmentation mammoplasty and received the same dose of EXPAREL. This primary objective of this study was to assess the efficacy of EXPAREL when administered via infiltration versus instillation as part of bilateral augmentation mammoplasty. The secondary objectives were to further assess other efficacy measures and the safety profile of EXPAREL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18-75 years of age inclusive.
- •American Society of Anesthesiologists (ASA) physical status 1-
- •Undergoing bilateral augmentation mammoplasty without any concurrent surgical procedure(s).
- •Physically and mentally able to participate in the study and complete all study assessments.
- •Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the study components.
排除标准
- •History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- •Any subject whose anatomy or surgical procedure might, in the opinion of the Investigator, preclude the potential successful local administration of EXPAREL.
- •Subjects currently pregnant or who may become pregnant during the course of the study.
- •Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
- •Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
研究组 & 干预措施
Infiltration - EXPAREL
Group 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery.
干预措施: Instillation - EXPAREL (Drug)
Instillation - EXPAREL
Group 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery.
干预措施: Infiltration - EXPAREL (Drug)
结局指标
主要结局
Duration of Analgesia
时间窗: 10 days
The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration.
次要结局
- Pain Intensity Assessment Upon Waking in the PACU(Upon waking in the PACO post surgery)
- Pain Intensity Assessment at the Time of Hospital Discharge(At the time of hospital discharge)
- Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10(Day 10 after surgery)
- Total Postsurgical Opioid Consumption in the Surgical Center(10 days)
- Time to Hospital Discharge Being Written(At the time of hospital discharge)
- Incidence of Opioid-Related Adverse Events(Through 10 Days Post Surgery)
- Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge(At the time of hospital discharge)