Efficacy of the Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Total Opioid Consumption
研究概览
简要总结
A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries.
详细描述
A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries. Subjects of prospective study will be randomly divided using electronic program into two groups:
The first group will receive intraoperative local Liposomal Bupivacaine injection at the port placement site. The control group will receive will local Marcaine (bupivacaine HCl) injection
Primary Outcome Measures:
- Total opioid consumption measured in intravenous morphine equivalents dose during the postoperative hospital Stay
- Postoperative pain assessment using visual Analog Pain Scores & Brief Pain Inventory form.
- Length of Hospital Stay
- Time to First Opioid Use.
- Postoperative Constipation , paralytic ileus
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
- •Patients undergoing urologic surgery.
排除标准
- •Pregnant and/or nursing mothers.
- •Allergy to bupivacaine.
- •History of drug/alcohol abuse.
- •Severe cardiovascular, hepatic, renal disease or neurological impairment.
研究组 & 干预措施
Exparel
This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.
干预措施: Exparel (Drug)
Marcaine
This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.
干预措施: Marcaine (Drug)
结局指标
主要结局
Total Opioid Consumption
时间窗: Postoperative days 1-3
Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively
Postoperative Pain Assessment
时间窗: Postoperative day 1
Pain score (0-10) will be used. This will be based on a standard visual analog scale, where 0 indicates no pain and 10 indicates the most severe pain reported by patients.
Postoperative Complications
时间窗: 30 days postoperatively
Any complication related to the surgery within 30 days
Length of Hospital Stay
时间窗: Duration of stay in hours
Duration of hospital stay after the surgery until time of discharge
次要结局
未报告次要终点
研究者
D. Duane Baldwin
Professor
Loma Linda University