NCT01801124已完成4 期
Evaluation of the Safety and Efficacy of EXPAREL® When Infiltrated Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Unilateral Abdominal Hernia Repair
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Overall Postsurgical Analgesic Use
研究概览
简要总结
Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).
详细描述
This is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, aged 18-75 years inclusive, and ASA physical status 1-
- •Undergoing open repair of a unilateral abdominal hernia below the level of the umbilicus.
- •Abdominal incision length of 3-12 cm.
- •Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- •Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.
排除标准
- •History of 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 infiltration.
- •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.
- •Any female subject who is currently pregnant.
- •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
Experimental
undiluted EXPAREL 266 mg
干预措施: EXPAREL (Drug)
结局指标
主要结局
Overall Postsurgical Analgesic Use
时间窗: 10 days
The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)
次要结局
- Postsurgical AEs and SAEs Through Day 30.(30 days)
研究者
研究点 (1)
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