Transversus Abdominus Plane (TAP) Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery: A Prospective Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Mean Opioid Consumption in Morphine Opioid Equivalents in mg
研究概览
简要总结
This is a prospective randomized study designed to compare the pain control from a single shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters with ropivicaine bolus in patients undergoing elective colorectal surgery.
详细描述
At UC Davis, it is standard practice to place TAP blocks with catheters for adult colorectal surgery patients for perioperative pain control. This practice, however, is resource intensive, adds the risk of catheter-related complications, and adds increased burden to patients by requiring them to be tethered to 2 catheters.
An alternative TAP can be performed using a single shot of liposomal bupivacaine (Exparel), an extended release local anesthetic that is FDA-approved for surgical plane infiltration including TAP blocks.
With this prospective study, we seek to improve patient care at UC Davis and educate other institutions through the use of concrete data comparing these 2 treatment options.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective colorectal surgery with Dr. Linda Farkas
排除标准
- •Patients under 18 years of age
- •Patient over 90 years of age
- •Pregnancy
- •Prisoners
- •Patients unable to provide consent
- •Patients on systemic anticoagulation therapy
- •Patients with an allergy to local anesthetics
研究组 & 干预措施
Group 1
Single injection of Exparel
干预措施: Exparel (Drug)
Group 2
Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Mean Opioid Consumption in Morphine Opioid Equivalents in mg
时间窗: 48 hours from start of surgery
Anticipate superior efficacy and pain control with liposomal bupivacaine TAP blocks measured by use of opioids (measured in oral morphine equivalents) in the first 48 hours following surgery Will use opioid consumption in morphine equivalents as a comparison
次要结局
未报告次要终点