Evaluation of the Safety and Efficacy of EXPAREL(R) (Bupivacaine Liposome Injectable Suspension) When Administered Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 主要终点
- Duration of Analgesia
研究概览
简要总结
The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.
详细描述
This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.
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
- •Females, 18-75 years of age inclusive.
- •American Society of Anesthesiologist (ASA) physical status 1-
- •Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) 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 TAP.
排除标准
- •Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- •Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP.
- •Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
- •Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
- •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
EXPAREL Group 1
EXPAREL 266 mg diluted with saline to a volume of 40 mL
干预措施: EXPAREL (Drug)
EXPAREL Group 2
EXPAREL 266 mg diluted with saline to a volume of 60 mL
干预措施: EXPAREL (Drug)
结局指标
主要结局
Duration of Analgesia
时间窗: End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)
次要结局
- Incidence of Adverse Events(10 days post surgery plus or minus 3 days)