The Use of Liposomal Bupivacaine in TAP Blocks for Women Undergoing Cesarean Section
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Postoperative narcotic use
研究概览
简要总结
This present investigation aims to determine whether a transversus abdominous plane(TAP) block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section decreases post-operative pain. The hypothesis is that performance of the TAP block with liposomal bupivacaine will decrease post-operative narcotic use.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients >18 years of age
- •Scheduled cesarean section with or without bilateral tubal ligation
- •Planned performance of a Pfannenstiel incision
- •Patients are schedule to have a cesarean section with a member of the Women's Health or Maternal and Fetal Medicine Departments at Penn State University Hershey S. Medical Center
排除标准
- •History of opioid use
- •History of chronic pain syndrome
- •Use of general anesthesia during cesarean delivery
- •Postoperative SICU admission
- •Postpartum hemorrhage (defined as an Estimated Blood Loss of greater then 1,000mL upon completion of the cesarean section)
研究组 & 干预措施
Intervention-Tap block w Liposomal bupivacaine
After completion of surgery w closure of skin incision a TAP block will be performed. On confirmation of entering the fascial plane, Liposomal bupivacaine 0.33% (10 ml diluted to 20 ml using sterile normal saline) will be injected after negative aspiration. That will complete the intervention. 20 patients will be in this arm
干预措施: TAP block w Liposomal bupivacaine (Drug)
Placebo- Tap block w normal saline
After completion of surgery with closer of skin incision a TAP block will be performed. On confirmation of entering the fascial plane, 20cc of Normal saline will be injected after negative aspiration. That will complete the intervention. 20 patients will be in this arm
干预措施: TAP block w normal saline (Procedure)
结局指标
主要结局
Postoperative narcotic use
时间窗: initial 48 hours postoperatively
Patient use of standard postoperative narcotics (percocet) will be measured.
次要结局
- Subjective pain scores using 1-10 VAS system(initial 48 hours postoperatively)
研究者
Jaimey M. Pauli, MD
OB/GYN Resident
Milton S. Hershey Medical Center