TAP (Transverse Abdominis Plane) Block With Exparel (Liposomal Bupivicaine) vs. Bupivicaine Post-op Pain Management
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Pain Scale
研究概览
简要总结
Single Blind, Randomized Controlled study to see if TAP Block with Exparel provides better pain relief than TAP Block with bupivicaine. Differences in Pain Scale, Length of Stay, and Total Narcotic use in the hospital will be evaluated.
详细描述
Subjects recruited into the study will undergo surgery as scheduled. During the procedure they will receive a TAP Block with one of the pain medications. TAP Block in the experimental arm will be performed with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline. The control arm will have a TAP Block performed with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline. These doses are consistent with prior studies of TAP Block with liposomal bupivacaine. Subjects will be monitored for pain as per standard of care and will be given pain medication as needed.
Subject Recruitment and Screening Patients will be recruited from the Ochsner Colorectal Surgery Clinic at the time of a preoperative visit.
Study Procedures
Screening & Baseline Visit After obtaining informed consent the subjects relevant medical and surgical history will be documented. Demographics and vitals will be documented. Current use of pain medication will be recorded. A physical exam will be performed.
Day of Surgery Routine vital signs will be obtained preoperatively. During the operation subject will receive a TAP Block containing their randomized local injection mixture as described above. Following surgery the subject will recover the PACU and pain medication will be provided on demand. Initial postoperative vital signs and pain scores will be obtained at this time.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age 18-75 years undergoing planned laparoscopic colon or rectal resection
排除标准
- •Patients younger than 18 or older than 75 years old
- •Pregnant women
- •Patients who have taken steroids or other immunomodulators within the last 6 months
- •Patients on home narcotics
- •Patients allergic to Exparel or bupivacaine
研究组 & 干预措施
TAP Block with Exparel
TAP Block with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline
干预措施: Pain Scale (Other)
TAP Block with Exparel
TAP Block with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline
干预措施: Exparel Injectable Product (Drug)
TAP Block with bupivicaine
TAP Block with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline
干预措施: Pain Scale (Other)
TAP Block with bupivicaine
TAP Block with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline
干预措施: Bupivacaine Injection (Drug)
结局指标
主要结局
Pain Scale
时间窗: daily through study completion (up to 30 days)
Daily Pain Scale using Wong-baker FACES Pain Rating Scale 0 (no pain) - 10 (worst pain imaginable)
次要结局
- Length of stay(daily through study completion (up to 30 days))
- Narcotic use(daily through study completion (up to 30 days))
