Intraoperative Surgeon Administered Transversus Abdominis Plan (TAP) Block With Liposomal Bupivacaine and Post-operative Pain Control After Repeat Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 40
- 主要终点
- Daily Narcotic Use in Morphine Equivalents
研究概览
简要总结
The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.
详细描述
Transversus abdominis plane (TAP) block is a well-described technique to provide a field block for analgesia. It has been shown to be effective in postoperative analgesia after cesarean delivery. TAP blocks are commonly performed post-operatively by anesthesiologists using liposomal bupivacaine with ultrasound guidance. Liposomal bupivacaine is an FDA approved medication for post-surgical analgesia and available at UMass-Memorial Medical Center. Liposomal bupivacaine provides sustained release of medication for up to 120 hours. A recent multicenter randomized controlled trial demonstrated the efficacy of anesthesiologist administered TAP blocks using liposomal bupivacaine after cesarean delivery. Infiltration of the skin and fascia with liposomal bupivacaine after cesarean did not have an effect and this can be explained by the path that the pain fibers take through the TAP which makes them amenable to a TAP block while a superficial infiltration is ineffective.The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women presenting for elective repeat cesarean delivery at 37-42 weeks gestational age.
- •Pregnancy and delivery care obtained at UMass Memorial Medical Center
- •Patients able to provide written informed consent
- •English, Spanish, or Portuguese-speaking patients
排除标准
- •Participants who are under the age of 18 years
- •Active labor.
- •Baseline pain score >
- •Unable to provide informed consent.
- •Prisoners will be excluded from this research.
- •Narcotic use in the 2 weeks prior to delivery.
- •Active substance abuse.
- •Inability to take narcotic analgesia.
结局指标
主要结局
Daily Narcotic Use in Morphine Equivalents
时间窗: From time of surgery through postpartum day 4
Daily Narcotic Use in Morphine Equivalents
次要结局
- Time to first administered narcotic (oral or parental)(From time of surgery through postpartum day 4)
- Daily Maximum Pain Score(From time of surgery through postpartum day 4)
- Daily Average Pain Score(From time of surgery through postpartum day 4)
- Time to First Ambulation(From time of surgery through postpartum day 4)
- Time to First Solid Food(From time of surgery through postpartum day 4)
研究者
Gianna Wilkie
Principal Investigator
University of Massachusetts, Worcester
