A Randomized Controlled Trial for Pain Control in Laparoscopic Urologic Surgery: 0.25% Bupivacaine Versus Long-Acting Liposomal Bupivacaine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay
研究概览
简要总结
A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic urologic surgeries in an effort to determine which method reduced postoperative opioid use the most.
详细描述
Liposomal bupivacaine was developed to extend the duration of efficacy of bupivacaine from the typical 6 - 8 hours up to 72 hours. The prolonged duration of liposomal bupivacaine was initially demonstrated in mice in 1994. Two randomized controlled trials using liposomal bupivacaine for bunionectomy and hemorrhoidectomy resulted in FDA approval for its use in humans. More recently, liposomal bupivacaine has also been found to improve pain control for patients undergoing total knee arthroplasty. Infiltration of a local anesthetic into laparoscopic port sites is a common practice that has been shown in some studies to improve postoperative pain. To compare liposomal bupivacaine and 0.25% bupivacaine for local analgesia following laparoscopic and robotic urologic surgery, a randomized comparison-controlled trial was performed.
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
- Single (Participant)
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
- •At least 18-years-old, undergoing laparoscopic urologic surgery.
排除标准
- •Pregnant and/or nursing mothers.
- •Allergy to bupivacaine.
研究组 & 干预措施
Bupivacaine
Surgical site infiltration of 0.25% bupivacaine.
干预措施: Bupivacaine (Drug)
Liposomal bupivacaine
Surgical site infiltration of liposomal bupivacaine.
干预措施: liposomal bupivacaine (Drug)
结局指标
主要结局
Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay
时间窗: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay
次要结局
- Visual Analog Pain Scores.(All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.)
- Length of Hospital Stay.(All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.)
- Time to First Opioid Use.(All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.)