Evaluation of the Safety and Efficacy of EXPAREL When Administered by Infiltration Into the Transversus Abdominis Plane (TAP) for Prolonged Postsurgical Analgesia in Subjects Undergoing Robot-assisted Laparoscopic Prostatectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The Duration of Abdominal Analgesia From Infiltration Into the TAP
研究概览
简要总结
The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.
详细描述
Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •male subjects, aged 18-
- •American Society of Anesthesiology (ASA) physical status 1-
- •Undergoing robot-assisted laparoscopic prostatectomy performed by a single surgeon (Ingolf Tuerk, MD).
- •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 TAP infiltration.
排除标准
- •Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
- •Inability to tolerate oxycodone with acetaminophen (e.g. Percocet).
- •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.
- •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 20 mL (undiluted)
20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen.
干预措施: EXPAREL 20 mL (Drug)
EXPAREL 40 mL (diluted)
20 mL (266 mg) EXPAREL diluted with an equal volume of preservative-free 0.9% normal saline to a total of 40 mL and infiltrated equally to the right and left side of the abdomen.
干预措施: EXPAREL 40 mL (Drug)
结局指标
主要结局
The Duration of Abdominal Analgesia From Infiltration Into the TAP
时间窗: First postsurgical administration of an opioid
次要结局
- Subject Reported Postsurgical Pain(1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP)
- Physician/Healthcare Professional Assessed Postsurgical Pain(1, 2, 6, 12, 24 hours after TAP)
- Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.(48, 72, 96 hours)
- Incidence of Prespecified Opioid-related Adverse Events(Until hospital discharge order was written, anticipated at 24 hours.)
- Overall Rating of Subject Satisfaction With Postsurgical Pain Control(24 hours, 72 hours, and day 10)