Transversus Abdominis Plane (TAP) Block Study for Postoperative Pain Control
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 主要终点
- Total Dosage of Narcotic
研究概览
简要总结
This clinical trial will examine differences in the effectiveness between three (3) commonly used methods and/or medications used to perform a transversus abdominis plane (TAP) block for post-operative pain control. The transversus abdominis muscle is either side between the lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine into the TAP. Group C subjects will be treated with a continuous infusion of the local anesthetic ropivacaine with the ON-Q® pump. There will be no placebo group in this study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to give written informed consent
- •Scheduled for open abdominal surgery
- •American Society of Anesthesiologists physical status 1 to 3
排除标准
- •Inability to understand the study or provide written informed consent
- •Inability to follow protocol instructions
- •Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery
- •Allergy to local anesthetic agents
- •Contraindication to regional nerve block such as:
- •Bleeding disorder
- •Infection at site of block
- •Body Mass Index (BMI) >40
- •Pregnancy
研究组 & 干预措施
Single Injection of Bupivacaine
Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
干预措施: Bupivacaine (Drug)
Single Injection of Exparel®
Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
干预措施: Exparel® (Drug)
Continuous infusion of Ropivacaine
Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Total Dosage of Narcotic
时间窗: 3 postoperative days
The total use of analgesic medications will be recorded during the 3 days immediately following surgery.
次要结局
- Number of Days Required for a Patient to Get Out of Bed(Assessed daily for up to 3 days post-surgery)
- Postoperative Vomiting (Events)(3 postoperative days)
- Patient Reported Pain by VAS Scale(Postoperative Day 3)
- Number of Days Required for a Patient to Walk Unassisted(Assessed daily for up to 3 days post-surgery)
研究者
Joshua Herskovic
Anesthesiologist
Midwestern Regional Medical Center