The Effect of Local Infiltration of Liposomal Bupivacaine on Opioid Consumption at Time of Cesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Opioid (narcotic medication) use
研究概览
简要总结
The aim of this study is to determine if local wound infiltration with liposomal bupivacaine at the time of cesarean delivery can decrease opioid use and provide adequate post-operative pain control.
详细描述
Specific Aim 1: To identify the effect of local infiltration of all wound layers with liposomal bupivacaine on opioid consumption up to 48 hours after cesarean delivery.
For this aim, in-patient narcotic use, measured in morphine equivalents, will be documented by the nurses and totaled during each 24 hour period after cesarean section until discharge.
Specific Aim 2: To identify the effect of local infiltration of all wound layers with liposomal bupivacaine on other, relevant, clinical outcomes, including time to first opiate use, time to mobility, occurrence of vomiting, use of rescue antiemetic medications, pain scores, and use of additional measures for pain control such as heating pads, muscle relaxers, gabapentin, between the study groups.
Specific Aim 3: To determine the occurrence of adverse events in the infants of breastfeeding women who have received local infiltration of all wound layers with liposomal bupivacaine compared to breastfeeding women who received saline infiltration.
Study Methods:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are between 18 and 45 years of age, inclusive.
- •Are undergoing a planned, primary or repeat, cesarean delivery without permanent sterilization.
- •Have a BMI ≤
- •Are able to read and understand English.
排除标准
- •Have pre-eclampsia with severe features.
- •Has been taking medication assisted treatment for opioid addiction during this pregnancy.
- •Have known sensitivity to local anesthetic.
- •Have a known sensitivity to non-steroidal anti-inflammatory medications.
- •Planning to have a tubal ligation after the cesarean delivery.
- •Are unable to receive neuraxial analgesia and/or Duramorph, a morphine formulation that is the standard of care for intrathecal anesthesia at MVH.
- •Are prisoners.
研究组 & 干预措施
liposomal bupivacaine infiltration
Local infiltration of all wound layers with liposomal bupivacaine (Exparel(R)) 20 ml diluted with 70 ml of normal saline to 90 ml for patient with a BMI of 39 and under. If BMI is 40 or more the 20 ml of liposomal bupivicaine will be diluted to 150 ml by adding 130 ml of normal saline
干预措施: Exparel (Drug)
Saline infiltration
Local infiltration of all wound layers with saline, using to match the amount. The amount of total fluid is divided into 4 and instilled with 1-2 ml at a time in between fascial layers after fascial closure. Each 1/4 will be instilled laterally (2) and on each side of the incision(2)- extra fluid is placed subcutaneously.
干预措施: Saline infiltration (Other)
结局指标
主要结局
Opioid (narcotic medication) use
时间窗: at the end of 48 hours after delivery
total opioid use, as morphine equivalents; sum of narcotic pain medications over 48 hours reported in morphine equivalents, by the Ohio Automated RX reporting system calculator, where hydrocodone 5 mg is 5 morphine equivalent dose (MED) and percocet 5 is 7.5 MED
次要结局
- Average pain scores Day 1(at the end of 24 hours after delivery)
- Average pain scores Day 2(at the end of 48 hours after delivery)
研究者
Marilyn J Kindig, D.O.
Assistant Professor
Wright State University