Stopping Opioid Overuse in Obstetrics to Halt Exposure Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Morphine Milligram Equivalents
研究概览
简要总结
As the opioid epidemic continues on, more research is needed on multi-modal approaches to decrease opioid exposure after common procedures. The aim of this study is to investigate the role of a transverses abdominis block using liposome bupivacaine suspension in reducing use of opioid medications through post-operative day 7. The study is a proposed double-blind, randomized controlled trial.
详细描述
Nearly 1 in 3 women in the US deliver by cesarean delivery. After cesarean delivery, approximately 75-87% percent of women are discharged from the hospital with an opioid prescription. Most women fill that prescription and 1% continue to use those opioids 90 days after delivery despite no longer requiring them for pain control, predisposing them to opioid dependence. This study aims to determine if transverse abdominis plane (TAP) block using bupivacaine liposome suspension injection (EXPAREL®) significantly reduces the use of opioid medications after discharge in women undergoing scheduled cesarean delivery. The study is a proposed double-blinded, randomized controlled trial. Pregnant women who have completed 37 weeks gestation and are scheduled for cesarean delivery will be randomized to receive a TAP block with 80 ml of mixed liposomal bupivacaine or saline. Based on its use in other surgical settings, the investigators hypothesize that women who receive a liposomal bupivacaine TAP block will use significantly less opioids by postoperative day 7 as calculated in morphine milligram equivalents. In addition to overall consumption of opioids after discharge, other aims to be studied include inpatient opioid use, effect on pain scores, rates of postpartum depression, patient-perceived quality of breastfeeding, patient quality of recovery, and composite adverse outcomes.
With better overall pain control and less dependence on opioids postpartum, liposomal bupivacaine TAP blocks at the time of scheduled cesarean delivery may offer a highly effective analgesic alternative that can help shift the tide in the ongoing opioid epidemic among reproductive females.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Unlabored, scheduled primary or repeat cesarean delivery
- •Cesarean performed by obstetrician or surgically-trained family medicine physician
- •Ability to complete numeric pain scale assessment and surveys
- •Patients who do not speak English but are able to converse via an interpreter both in person and by phone
排除标准
- •Complications requiring return to the operating room
- •Unscheduled deliveries
- •<18 years old, >45 years old
- •Twin deliveries
- •Preterm deliveries (<37 wks)
- •Current or previous history of opioid-substance use disorder according to patient report or medical chart
- •Prescription of opioid medication filled in previous 30 days prior to delivery according to patient report, documentation in electronic medical record, or documentation in the prescription drug monitoring program
- •Allergy to local anesthetics or NSAIDs
- •Cardiovascular disease, eg arrhythmia, or ASA (American Society of Anesthesiologists) Class III or higher
- •Diagnosis of liver disorder or dysfunction including fatty liver of pregnancy, preeclampsia with severe features including liver or kidney involvement
- •Known significant renal disease, oliguria, or Cr >1.
- •Platelet count less than or equal to 90k or rapid decline in third trimester or other coagulopathy
- •Infection overlying the regional anesthesia site
- •Hypovolemia prohibiting regional anesthesia
- •General anesthesia
研究组 & 干预措施
Treatment
The transversus abdominis plane block is a procedure involving injection of a local anesthetic solution into the abdominal plane between the internal oblique muscle and the transversus abdominis muscle. In our institution, this is done under ultrasound guidance which is the current standard to improve efficacy and limit complications. Liposomal bupivacaine uses an innovative technology consisting of lipid-based particles containing active pharmaceutical agent (bupivacaine) which extends the duration of the medication through a process of gradual release for metabolism.This drug delivery technology extends the duration of action to up to 96 hours when given at a dose of 266 mg liposomal bupivacaine admixed with 30 ml of bupivacaine 0.25% and 30 ml of saline. Forty ml of solution is deposited on the left side of the abdomen and 40 ml on the right.
干预措施: Liposomal bupivacaine (Drug)
Treatment
The transversus abdominis plane block is a procedure involving injection of a local anesthetic solution into the abdominal plane between the internal oblique muscle and the transversus abdominis muscle. In our institution, this is done under ultrasound guidance which is the current standard to improve efficacy and limit complications. Liposomal bupivacaine uses an innovative technology consisting of lipid-based particles containing active pharmaceutical agent (bupivacaine) which extends the duration of the medication through a process of gradual release for metabolism.This drug delivery technology extends the duration of action to up to 96 hours when given at a dose of 266 mg liposomal bupivacaine admixed with 30 ml of bupivacaine 0.25% and 30 ml of saline. Forty ml of solution is deposited on the left side of the abdomen and 40 ml on the right.
干预措施: TAP block (Procedure)
Control
The transversus abdominis plane block will be performed under ultrasound guidance with deposition of 80 ml of saline (40 ml on either side).
干预措施: TAP block (Procedure)
Control
The transversus abdominis plane block will be performed under ultrasound guidance with deposition of 80 ml of saline (40 ml on either side).
干预措施: Deposition of saline (Drug)
结局指标
主要结局
Morphine Milligram Equivalents
时间窗: 7 days after cesarean
Amount of opioid medications taken converted to Morphine Milligram Equivalents
次要结局
- Opioid-spared Percentage(Inpatient stay up to 6 days)
- Time to as needed opioid use(Inpatient stay up to 6 days)
- Edinburgh Postpartum Depression Scale Score at 6 wks(6 weeks postpartum visit)
- Numeric Rating Scale Pain Score Postoperative day #7(Postoperative day #7)
- Quality of Recovery-15 at discharge(Inpatient stay up to 6 days)
- Quality of Recovery-15 at Postoperative day #14(Postoperative day #14)
- Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #7(Postoperative day #7)
- Morphine Milligram Equivalents at 48 hours(Time surgery is complete to 48 hours)
- Numeric Rating Scale Pain Score on postoperative day 1(Midnight to midnight postoperative day #1)
- Edinburgh Postpartum Depression Scale Score at Discharge(Inpatient stay up to 6 days)
- Numeric Rating Scale Pain Score at Postoperative day #14(Postoperative day #14)
- Numeric Rating Scale Pain Score at 6 wks(Postpartum visit 6 wks)
- Breastfeeding Self-Efficacy Scale Short Form at Postoperative day #14(Postoperative day #14)
- Edinburgh Postpartum Depression Scale Score at 7 days(Postoperative day #7)
- Edinburgh Postpartum Depression Scale Score at 14 days(Postoperative day #14)
- Quality of Recovery-15 at 7 day(Postoperative day #7)
- Quality of Recovery-15 at 6 weeks(Postpartum visit 6 weeks)
- Breastfeeding Self-Efficacy Scale Short Form at 6 weeks(Postpartum 6 weeks)
- Adverse Events(Study duration ~ 8 weeks)
研究者
Traci N Johnson
Principal Investigator
University of Missouri, Kansas City