Evaluation of Aerosolized Bupivacaine Versus Pre-incision Lidocaine Versus Instilled Liquid Bupivacaine Versus Post-operative Bupivacaine Injection for Optimization of Post-operative Pain Control in Laparoscopic Bariatric Surgical Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measure of reduction in post-operative pain and narcotics usage.
研究概览
简要总结
The purpose of this study is to determine if pre-incisional lidocaine injection, instilled liquid bupivacaine, intra-abdominal aerosolized bupivacaine, or post-operative bupivacaine injection is superior in post-operative pain control in laparoscopic bariatric surgical patients.
详细描述
The research objective is to compare our standard post-operative port site injection of 0.5% bupivacaine against pre-incisional port site injection of 1% lidocaine against the instillation of streamed bupivacaine 0.5% against the instillation of aerosolized 0.5% bupivacaine as it relates to post-operative analgesia usage and pain scale scores. The null hypothesis will be that there is no difference between the four arms of the study in regards to pain score and analgesia usage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients between 18 and 65 years of age.
- •Patients undergoing elective bariatric surgery.
排除标准
- •Patients allergic to bupivacaine or any other local anesthetics (amides & esters).
- •Patients who have used opiates or opiods within 15 days prior to surgery.
- •Patients converted to open gastric bypass.
研究组 & 干预措施
3
干预措施: Streamed bupivacaine versus streamed normal saline (Drug)
2
干预措施: Injected lidocaine pre-incision vs saline pre-incision (Drug)
4
干预措施: Aerosolized bupivacaine versus aerosolized saline (Drug)
1
干预措施: Injected bupivacaine post-operatively (Drug)
结局指标
主要结局
Measure of reduction in post-operative pain and narcotics usage.
时间窗: First 3 days post-operatively.
次要结局
未报告次要终点
研究者
Troy Moritz, D.O.
Troy Moritz DO
Pinnacle Health System