Comparative Effectiveness of Bupivacaine-Dexamethasone-Epinephrine Versus Exparel in Postoperative Outcomes for Hernia Patients Undergoing Abdominal Wall Reconstruction
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Morphine Milligram Equivalent
研究概览
简要总结
This trial compares how two different numbing medications help patients feel the least amount of pain while recovering from surgery.
详细描述
This will be a prospective randomized controlled trial comparing the outcomes of hernia patients receiving BDE versus Exparel before abdominal wall reconstruction. The study will utilize the pain numeric rating scale (PNRS) validated questionnaire to assess pain levels. Patients will be asked to report their worst pain imaginable.
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
- Double (Participant, Investigator)
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
- •Any preoperative robotic and open abdominal wall surgery patient who will receive a transversus Abdominis Plane (TAP) block in the BSW health care system who agrees to participate in the study
- •Patients 18 years and above
排除标准
- •Patients not undergoing abdominal wall reconstruction surgery
- •Pregnant patients- Patients with childbearing potential undergo serum pregnancy test as per standard of care pre-procedure. If they are found to test positive, they will be excluded from the study.
- •Patients less than 18 years old
- •Patients receiving any additional regional anesthesia outside the study protocol prior to surgery.
- •Patients undergoing additional planned surgical procedures during the same admission
- •History of chronic pain or chronic opioid use Known allergy to BDE or Exparel or to drugs included as part of multimodal regimen { acetaminophen, gabapentin or Lyrica (pregabalin)}.
研究组 & 干预措施
BDE for hernia patients
112.5 mg of bupivacaine, 3mg dexamethasone and 0.15 mg of epinephrine. In a 30mL syringe. This will be administered into the transversus abdominis plane on both sides.
干预措施: BDE Injectable Drug (Drug)
Exparel for hernia patients
266mg (20ml) mixed with 30 mls of 0.25% marcaine, administered via syringe in the transversus abdominis plane on both sides.
干预措施: Exparel Injectable Drug (Drug)
结局指标
主要结局
Morphine Milligram Equivalent
时间窗: Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)
To evaluate the difference in medication usage/ Morphine Milligram Equivalent (MME) between the two groups
Pain control
时间窗: Baseline, Surgery Day, Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)
Compre efficacy in pain control by using the PNRS Questionniare
Hospital Stay
时间窗: 30-45 days after hospital discharge
To compare the length of hospital, stay between patients receiving BDE and those receiving Exparel.
次要结局
- Bowel Function(30-45 days after hospital discharge)
- Total Cost(30-45 days after hospital discharge)