Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Patient Satisfaction With Pain Management After Surgery
研究概览
简要总结
The purpose of this study is to learn how well Liposomal Bupivacaine (Exparel™) controls post-operative pain in patients undergoing both open and laparoscopic (minimally invasive) abdominal hernia repair surgery.
详细描述
When a person has surgery, there are a few different standard care options for pain relief. Anesthetic (numbing) drugs can be used to cause a loss of feeling in or around a wound but the effect of the numbing medication can be undone.Pain relieving drugs such as acetaminophen (Tylenol), non-steroidal anti-inflammatory drugs (NSAIDs), and opioid (narcotic) medications can also be taken by mouth or through a vein in your arm (intravenous IV.) However, both NSAIDs & Opioid drugs can produce negative side effects such as serious difficulty breathing, stopping breathing altogether, low blood pressure, nausea, vomiting, itching, and constipation.
Bupivacaine is one of the commonly used longer-acting numbing medicines (anesthetics). The effect of Bupivacaine or other anesthetics is limited to usually no more than 12 hours when injected around the area of the incision during surgery. Liposomal Bupivacaine (Exparel) could provide good, continuous and longer pain relief than current therapies/treatments commonly used. This can possibly improve patient satisfaction and time to normal activities such as walking.
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
- •Patients scheduled to undergo an open or laparoscopic abdominal hernia repair.
- •Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.
排除标准
- •Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioids or ketorolac.
- •Patients who abuse alcohol or other drug substance.
- •Patients who are on chronic opioid therapy (taken an opioid 5 of the last 7 days).
- •Patients with severe hepatic impairment.
- •Patients currently pregnant.
研究组 & 干预措施
Treatment Group 1
Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 1 will have an open surgery for abdominal hernia repair.
干预措施: EXPAREL (Drug)
Treatment Group 1
Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 1 will have an open surgery for abdominal hernia repair.
干预措施: Ketorolac (Drug)
Treatment Group 1
Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 1 will have an open surgery for abdominal hernia repair.
干预措施: an open surgery for abdominal hernia repair (Procedure)
Treatment Group 2
Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 2 will have a laparoscopic abdominal hernia repair.
干预措施: EXPAREL (Drug)
Treatment Group 2
Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 2 will have a laparoscopic abdominal hernia repair.
干预措施: Ketorolac (Drug)
Treatment Group 2
Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 2 will have a laparoscopic abdominal hernia repair.
干预措施: laparoscopic abdominal hernia repair (Procedure)
Control Group 1
Patients scheduled in Control Group 1 will have an open surgery for abdominal hernia repair. The Control Group patients will receive traditional treatment.
干预措施: an open surgery for abdominal hernia repair (Procedure)
Control Group 2
Patients scheduled in Control Group 2 will have laparoscopic abdominal hernia repair. The Control Group patients will receive traditional treatment.
干预措施: laparoscopic abdominal hernia repair (Procedure)
结局指标
主要结局
Patient Satisfaction With Pain Management After Surgery
时间窗: Change from Surgery to Day 14
Satisfaction measured with composite score that includes score from the Likert scale and opioid consumption/satisfaction log. Satisfaction was rated on a scale of 1-5, with 1 being "strongly disagree"/not satisfied with pain control and 5 being "strongly agree"/satisfied with pain control. Patients filled out the log on days 1-4 after surgery and at a 7-14 day follow up visit.
次要结局
- Total Length of Time in Post-anesthesia Care Unit (PACU)(Up to 385 minutes after surgery)