Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Verbal Pain Scale (VRS) - 4 Week Post-op
研究概览
简要总结
To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include date of ambulation, return of bowel function (first flatus), tolerance of goal diet, incidence of post-operative nausea and vomiting during hospital stay, length of stay (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and quality of life on follow up.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75 years
- •Elective laparoscopic colorectal surgery
- •ASA I-III
排除标准
- •Contraindication to Na Channel Blocker
- •Chronic Opioid use
- •Liver dysfunction
- •Renal insufficiency
- •Psychomotor retardation
- •Sleep Apnea
- •Cardiac Rhythm Disorders
- •Planned open or concomitant procedure
研究组 & 干预措施
CONTROL: IV Lido
CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)
干预措施: IV Lidocaine (Drug)
EXPERIMENTAL: Exparel
EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)
干预措施: Exparel (Drug)
结局指标
主要结局
Verbal Pain Scale (VRS) - 4 Week Post-op
时间窗: Single VRS assessed at 4-week post-op visit (or phone call)
Postoperative pain was measured by verbal rate scale (VRS) Scale of 0-10 at instance of 4-week post-op visit (or phone call). 0 represents no pain while 10 represents worst possible pain.
次要结局
未报告次要终点