Prospective Randomized Trial of Liposomal Versus Plain Bupivacaine in Minimally Invasive General Surgery Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total post operative narcotic use in morphine equivalents.
研究概览
简要总结
Aim: To compare the postoperative outcomes after surgical infiltration with plain bupivacaine compared to liposomal bupivacaine in patients undergoing elective, minimally invasive, general surgery procedures. To the investigators knowledge, there are no head-to-head, prospective, randomized, controlled trials of plain bupivacaine versus liposomal bupivacaine to evaluate postoperative pain and return of function.
详细描述
The investigators current standard has been to use liposomal bupivacaine routinely for surgical infiltration which was a change from the historical practice of infiltration with lidocaine/bupivacaine, plain bupivacaine or no local anesthetic at all. The change was made due to the perceived benefits in analgesia past the 12-24 hours that plain bupivacaine was effective. It is not clear, however, that there are statistically significant benefits in terms of reduced narcotic use and length of hospital stay and improved pain control and return of function post-operatively.
Primary outcomes: The investigators will then measure narcotic use post-operatively as calculated by combining measures of patient-controlled analgesia (PCA) use for first 24 hours added to in-patient oral narcotic use (by referencing the electronic medical record (EMR)) as well as out-patient oral narcotic use as reported by patients. Subjective pain levels and pain interference scale and physical functioning scale will be evaluated pre-operatively and post-operatively with use of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) developed by the Defense and Veterans Center for Integrative Pain Management (DVCIPM) as a measure of perioperative pain and function.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 years or older
- •American Society of Anesthesiologists (ASA) status 1, 2 or 3
- •Having an elective, minimally invasive, general surgery procedure at Naval Medical Center San Diego (NMCSD)
排除标准
- •Age: Younger than 18 years old
- •Pregnant women - safety of liposomal bupivacaine has not been studied in pregnant women
- •ASA status greater than or equal to 4
- •Conversion to open procedure/laparotomy
- •History of reaction to local anesthetics
- •History of hepatic disease - local anesthetics are metabolized in the liver
- •History of pre-operative/concurrent condition requiring narcotic use
- •Patient not able to adhere to post-operative pain control regimen outlined in methods section
研究组 & 干预措施
Liposomal Bupivicaine arm
Post procedure, infiltrate wounds with liposomal bupivacaine
- Liposomal Bupivacaine (Brand name Exparel) 266 milligram (mg)/20 mL to be diluted to 30 mL with normal saline
- 10 mL of study drug to be injected at each 10-12 millimeter (mm) trocar site and 5 mL of study drug to be injected at the 5 mm trocar sites. Typically there are two 10 mm trocar sites and three 5 mm trocar sites.
干预措施: liposomal bupivicaine (Drug)
Plain Bupivicaine
- Post procedure, infiltrate wounds with plain bupivicaine
- Plain Bupivacaine 0.25%, volume of 30 mL
- 10 mL of study drug to be injected at each 10-12 millimeter (mm) trocar site and 5 mL of study drug to be injected at the 5 mm trocar sites. Typically there are two 10 mm trocar sites and three 5 mm trocar sites.
干预措施: liposomal bupivicaine (Drug)
结局指标
主要结局
Total post operative narcotic use in morphine equivalents.
时间窗: Up to fourteen days.
To be measured by combining measures of Patient-Controlled Analgesia pump use for the first 24 hours added to in-patient oral narcotic use (by referencing the electronic medical record (EMR) and out-patient oral narcotic use as reported by patients.
次要结局
- Length of hospital stay post operative procedure.(up to fourteen days.)
- Pain level pre and post operative procedure.(Up to fourteen days.)
- Post operative procedure physical functioning level.(Up to fourteen days.)
- Number of post operative procedure adverse events.(Up to fourteen days.)